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Breathing Bag, 1L, Latex-Free
EUDAMEDClass I (EU MDR)
Ref 64101Model Disposable Reservoir Bag - Latex/Latex-FreeRef 64111
Identity
- Trade Name
- Breathing Bag, 1L, Latex-Free EUDAMEDBreathing Bag, 1L, Latex EUDAMED
- Device Name
- Breathing Bag EUDAMED
- Model / Reference
- Disposable Reservoir Bag - Latex/Latex-Free EUDAMED64101 EUDAMED64111 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04719897760015 EUDAMED04719897760084 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
EUDAMEDEUDAMED
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, 1L, 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 (2)
- EUDAMED 26ec2795-5d90-47a1-83b3-0150c28e4f01 61 fields · synced Jul 29, 2026
- EUDAMED 6c26ff57-0055-4e62-ae90-1874aba15b43 61 fields · synced May 17, 2026