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Breathing Bag, 0.5L, Latex
EUDAMEDClass IIa (EU MDR)
Ref AB0103Ref AB0017Ref AB0119
Identity
- Trade Name
- Breathing Bag, 0.5L, Latex EUDAMEDBreathing Bag, 0.5L, Latex Free EUDAMED
- Device Name
- Disposable Breathing bag EUDAMED
- Model / Reference
- AB0103 EUDAMEDAB0017 EUDAMEDAB0119 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06923980103384 EUDAMED06923980105326 EUDAMED06923980105340 EUDAMED
- Basic UDI-DI
- 69239801ND2CANL EUDAMED69239801ND2CBNN 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
- Spain EUDAMEDGermany EUDAMEDSweden EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
Yes
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, 0.5L, Latex 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 | 69239801ND2CANL | 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 (3)
- EUDAMED 2d75a81d-1452-4147-81cb-151db95067a8 61 fields · synced Aug 3, 2026
- EUDAMED 9bc3f377-a612-44f4-8ebf-52e8582c01d0 61 fields · synced May 17, 2026
- EUDAMED f6ef439c-1ea2-4b3c-adab-9b42ca73712e 61 fields · synced May 18, 2026