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Disposable Breathing Filters
EUDAMEDClass IIa (EU MDR)
Ref BVF-02Ref HMEF-01Ref HMEF-03
Identity
- Trade Name
- Disposable Breathing Filters EUDAMED
- Device Name
- Disposable Breathing Filters EUDAMED
- Model / Reference
- BVF-02 EUDAMEDHMEF-01 EUDAMEDHMEF-03 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06971486641855 EUDAMED06971486641817 EUDAMED06971486641831 EUDAMED
- Basic UDI-DI
- 6971486640261CF EUDAMED
- EMDN Code
- R040102 ANTIBACTERIAL AND ANTIVIRAL RESPIRATORY FILTERS HUMIDIFIERS EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Germany EUDAMED
Clinical & Handling
Sterile
Yes
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
Reprocessed
No
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Disposable Breathing Filters by Shaoxing Reborn Medical Devices Co., Ltd. — Class IIa — MDR — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 6971486640261CF | Class IIa | Active |
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Manufacturer
- Manufacturer
- Shaoxing Reborn Medical Devices Co., Ltd.
- EUDAMED SRN
- CN-MF-000016475
- Authorised Representative
- MedPath GmbH DE-AR-000000087
Sources (3)
- EUDAMED b3e04b79-fdb8-4be7-82c4-d9ecb5be528b 61 fields · synced Jul 22, 2026
- EUDAMED 59716520-3d43-4c80-a093-3c4e5e2800bb 61 fields · synced May 17, 2026
- EUDAMED 7217646a-2196-4e2f-be33-8bd790787f81 61 fields · synced May 18, 2026