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Breathing Bag, 0.5L, Latex-Free
EUDAMEDClass I (EU MDR)
Ref 64104Model Disposable Reservoir Bag - Latex/Latex-Free
Identity
- Trade Name
- Breathing Bag, 0.5L, Latex-Free EUDAMED
- Device Name
- Breathing Bag EUDAMED
- Model / Reference
- Disposable Reservoir Bag - Latex/Latex-Free EUDAMED64104 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04719897760046 EUDAMED
- Basic UDI-DI
- 471989776641NL 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, 0.5L, Latex-Free 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 | 471989776641NL | 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 e084a2ff-ac4a-41d1-821c-0b1797fb8f95 61 fields · synced Jul 15, 2026