Identity
- Trade Name
- Breathing Bag, 2L, Latex Free EUDAMEDBreathing Bag, 2L, Latex EUDAMED
- Device Name
- Disposable Breathing bag EUDAMED
- Model / Reference
- AB0019 EUDAMEDAB0105 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06923980104701 EUDAMED06923980103131 EUDAMED
- Basic UDI-DI
- 69239801ND2CBNN EUDAMED69239801ND2CANL 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 EUDAMEDSpain 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, 2L, 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 67474401-b6f2-4493-8a57-b6a824228ce4 61 fields · synced Jul 31, 2026
- EUDAMED 326d5d7d-49e1-41b2-99ac-3fac8d7a32ed 61 fields · synced May 18, 2026