2026-09-21 · KeXinMaterials 编辑团队

医疗箱 FDA CE 合规 B2B 采购:AED、急救、除颤器 (2026)

医疗箱保护挽救生命的设备 — AED、除颤器、急救包、药品、诊断设备。FDA / CE / ISO 13485 合规不可妥协。这是 2026 B2B 采购指南。

为什么医疗箱合规是单独类别

Medical cases carry devices that directly affect patient outcomes. Compliance is regulated, not optional.

Medical cases transport AEDs, defibrillators, first aid kits, intubation kits, oxygen masks, pharmaceuticals, and diagnostic equipment. Damage or contamination of these devices can directly harm patients.

Regulatory frameworks: FDA (US market), CE (EU market), Health Canada, TGA (Australia), PMDA (Japan), NMPA (China). Each requires specific material compatibility and traceability documentation.

For B2B buyers, medical case compliance is not a "nice to have" — it is a regulatory requirement. Non-compliant cases risk medical device recalls, FDA warning letters, and criminal liability.

FDA 兼容性声明

The FDA does not certify protective cases directly. The case manufacturer provides a compatibility statement that the device manufacturer incorporates into their FDA submission.

FDA compatibility statement declares: case material composition, absence of extractable / leachable substances that could contact medical device contents, compliance with FDA 21 CFR (Code of Federal Regulations) for food-contact materials where applicable, and absence of latex (for latex-allergic patients).

Most medical device manufacturers require a per-SKU compatibility statement from the case supplier. The statement covers shell material (PP / PE / ABS / PC), foam (PU / PE / EVA), and any hardware (latches, hinges, gaskets).

At KeXinMaterials we provide FDA compatibility statement per medical SKU. Standard SKUs pre-cleared. Custom OEM statements issued within 7 days of sample approval.

欧盟医疗市场 CE 标志

CE marking is mandatory for protective cases used in EU medical applications. The case itself may fall under the Medical Device Regulation (MDR) or be considered an accessory.

EU MDR 2017/745 (Medical Device Regulation) governs medical devices and accessories. A protective case used to transport a medical device may be classified as an accessory, requiring CE marking under MDR.

CE marking process for medical case: (1) Classify the case per MDR Annex VIII — typically Class I (low risk) accessory. (2) Compile technical documentation per Annex II. (3) Issue Declaration of Conformity (DoC). (4) Apply CE mark. (5) Register with EUDAMED database for medical device traceability.

For B2B buyers sourcing CE-marked medical cases, request the DoC and the technical documentation summary. Verify the case is registered with EUDAMED. CE marking without registration is non-compliant.

At KeXinMaterials we maintain CE technical documentation for our medical case SKUs. DoC + EUDAMED registration available on request. 5-7 day lead time for DoC issuance.

ISO 13485 质量管理

ISO 13485 is the medical device quality management standard. Case manufacturers serving medical device OEMs should hold ISO 13485 certification.

ISO 13485 specifies requirements for quality management systems where an organisation needs to demonstrate its ability to provide medical devices and related services that consistently meet customer and applicable regulatory requirements.

For protective case manufacturers serving medical device OEMs, ISO 13485 certification indicates the factory operates under medical-grade QMS — document control, traceability, CAPA (Corrective and Preventive Action), and post-market surveillance.

At KeXinMaterials we operate under ISO 9001:2015 (general QMS) plus ISO 13485-aligned quality procedures for medical SKU lines. Full ISO 13485 certification is a 12-month project (not yet certified as of 2026-09). For medical device programmes requiring ISO 13485, we partner with ISO 13485-certified case manufacturers in our supply chain.

材料兼容性:PP vs PE vs PU 泡沫

Medical cases require materials compatible with pharmaceutical and biological contact. Three options dominate.

PP (Polypropylene): FDA 21 CFR 177.1520 compliant for food contact. Good chemical resistance. Cost USD 1.80-2.50/kg. Standard for medical case shells.

PE (Polyethylene): FDA 21 CFR 177.1520 compliant. Slightly softer than PP. Good chemical resistance. Common for medical case shells and foam.

PU foam (Polyurethane): open-cell structure absorbs liquids. For medical use, must be sealed in waterproof liner or replaced with closed-cell PE foam. FDA-compatible PU available with additive package.

PE foam (closed-cell Polyethylene): waterproof, chemical-resistant, FDA-compatible. Standard for medical case foam interiors. Density 28-45 kg/m³.

EVA foam (Ethylene-Vinyl Acetate): high-rebound, closed-cell, FDA-compatible. Used for premium medical device interiors (defibrillator, ultrasound).

At KeXinMaterials we stock PP shell + PE foam as standard medical case SKU. PU available with waterproof liner. EVA on request for premium medical SKUs.

按医疗应用划分的箱体设计

Medical cases are designed for specific applications. The case geometry, foam cutouts, and accessories vary significantly.

• AED Case (Automated External Defibrillator): Compact size 450x350x180mm. Foam cutouts for AED unit, 2 spare pads, 1 spare electrodes, scissors, razor, towel. IP65 minimum for outdoor placement. Pressure-equalisation valve.
• Defibrillator Case (hospital / EMS): Larger size 600x450x250mm. Foam cutouts for monitor / defibrillator, paddles or pads, ECG cables, SpO2 sensor, blood pressure cuff, batteries.
• First Aid Kit Case: Compact 350x250x150mm. Removable tray dividers for bandages, gauze, antiseptic, gloves, instruments. IP54 minimum.
• Pharma Transport Case: Insulated 600x450x300mm. Temperature-stable 2-8°C for 12-24 hours (with cold pack). Foam cutouts for vials, ampoules, syringes. Cold-chain validated.
• Diagnostic Device Case: Custom size. Foam cutouts for specific instruments (glucometer, ultrasound, oximeter, laryngoscope). Soft-touch interior lining.
• Intubation / Airway Kit Case: Compact 400x300x150mm. Foam cutouts for laryngoscope, blades, endotracheal tubes, syringes, bougie, suction.

起订量、交期、定价

Medical cases fall into three pricing tiers. Match tier to programme size.

Tier 1 (Stock medical SKU): MOQ 50-100 cases, USD 130-220/unit, 15-25 days production. FDA compatibility statement included. CE documentation available on request.

Tier 2 (Custom OEM medical): MOQ 100-300 cases, USD 180-350/unit (case + custom foam + FDA statement), 30-45 days production. CE technical documentation issued.

Tier 3 (New mould medical): MOQ 1,000+ cases amortised over 12-24 months, USD 150-280/unit post-amortisation, 60-90 days mould + 30-45 days production. Full MDR technical file.

Sample fee: USD 200-500 stock + foam, USD 500-1,500 new mould. Refundable against order ≥ 1,000 pieces.

为什么选择 KeXinMaterials 医疗箱

KeXinMaterials operates 60+ injection machines in a 13,000 m² facility since 2014. FDA compatibility statements per medical SKU. CE documentation available. ISO 13485-aligned QMS for medical SKUs.

Material: PP shell (FDA 21 CFR 177.1520 compliant), PE foam (closed-cell, waterproof, FDA-compatible). EVA available on request. PU available with waterproof liner.

Certifications: ISO 9001:2015, FDA compatibility statement per medical SKU, CE documentation on request, REACH compliance for EU export. Per-lot batch test certificate.

Medical SKU range: AED case, defibrillator case, first aid kit case, pharma transport case, diagnostic device case, intubation kit case. 50-100 piece MOQ for stock. Custom OEM at 100-300 pieces.

Trade terms: EXW Shenzhen / FOB Shenzhen / FOB Ningbo. No DDP, no EU warehouse, no US warehouse. Every shipment direct from our 13,000 m² Guangdong facility.

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