Identity
- Trade Name
- Breathing Bag, 1L, Latex Free EUDAMED
- Device Name
- Disposable Breathing bag EUDAMED
- Model / Reference
- AB0018 EUDAMEDAB0120 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06923980105333 EUDAMED06923980105357 EUDAMED
- Basic UDI-DI
- 69239801ND2CBNN EUDAMED
- EMDN Code
- R028099 RESPIRATORY CIRCUITS AND MOUNT CATHETERS - ACCESSORIES NOT INCLUDED IN OTHER CLASSES EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- France EUDAMEDSweden 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, 1L, Latex Free by GaleMed (Xiamen) 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 | 69239801ND2CBNN | Class IIa | Active |
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Manufacturer
- Manufacturer
- GaleMed (Xiamen) Co., Ltd.
- EUDAMED SRN
- CN-MF-000020627
- Authorised Representative
- Emergo Europe B.V. NL-AR-000000116
Sources (2)
- EUDAMED 20a79d7f-a023-465e-94ca-b6f2a08c5864 61 fields · synced Jul 18, 2026
- EUDAMED 424b44e9-2eff-4c6d-9310-87257e8ecb04 61 fields · synced May 19, 2026