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Breathing Bag, 2L, Silicone, w/ Over-MoldCuff
EUDAMEDClass I (EU MDR)
Ref 64202Model Disposable Reservoir Bag - Silicone
Identity
- Trade Name
- Breathing Bag, 2L, Silicone, w/ Over-MoldCuff EUDAMED
- Device Name
- Disposable Silicone Breathing Bag EUDAMED
- Model / Reference
- Disposable Reservoir Bag - Silicone EUDAMED64202 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04719897760282 EUDAMED
- Basic UDI-DI
- 471989776642NN EUDAMED
- EMDN Code
- R03020199 VENTILATION BALLOONS - OTHER EUDAMED
Classification
- Device Class
- Class I EUDAMED
Clinical & Handling
Sterile
No
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
Breathing Bag, 2L, Silicone, w/ Over-MoldCuff by Winnomed Company Ltd. — Class I — MDR — listed in EUDAMED — regulatory data on deviCERTS
Manufacturer's product page: Silicone Breathing Bag
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 | 471989776642NN | Class I | Active |
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Manufacturer
- Manufacturer
- Winnomed Company Ltd.
- EUDAMED SRN
- TW-MF-000037459
- Authorised Representative
- Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001
Sources (1)
- EUDAMED 353a6e88-fdde-4473-b6a5-67e2d8c322ea 61 fields · synced Jun 18, 2026