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Breathing Bag, 3L, Latex
EUDAMEDClass I (EU MDR)
Ref 64113Model Disposable Reservoir Bag - Latex/Latex-FreeRef 64133
Identity
- Trade Name
- Breathing Bag, 3L, Latex EUDAMEDBreathing Bag, 3L, Latex, with loop end, Black EUDAMED
- Device Name
- Breathing Bag EUDAMED
- Model / Reference
- Disposable Reservoir Bag - Latex/Latex-Free EUDAMED64113 EUDAMED64133 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04719897760107 EUDAMED04719897760237 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
Yes
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, 3L, Latex 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 f328928d-4f28-4c37-944a-3feca87e29eb 61 fields · synced Jul 9, 2026
- EUDAMED a4565440-6259-40ba-9155-d8bf6f4b6e4e 61 fields · synced May 18, 2026