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Breathing Bag, 0.5L, Latex Free
EUDAMEDClass IIa (EU MDR)
Ref AB0119Model (I) Anesthesia CircuitRef AB0103
Identity
- Trade Name
- Breathing Bag, 0.5L, Latex Free EUDAMEDBreathing Bag, 0.5L, Latex EUDAMED
- Device Name
- Breathing Bag EUDAMED
- Model / Reference
- (I) Anesthesia Circuit EUDAMEDAB0119 EUDAMEDAB0103 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04710810083167 EUDAMED04710810084874 EUDAMED
- Basic UDI-DI
- 471081008NNI37P EUDAMED
- EMDN Code
- R02010101 BREATHING CIRCUITS, W/O WATER TRAP EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Netherlands 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, 0.5L, Latex Free by GaleMed Corporation — 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 | 471081008NNI37P | Class IIa | Active |
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Manufacturer
- Manufacturer
- GaleMed Corporation
- EUDAMED SRN
- TW-MF-000022411
- Authorised Representative
- Emergo Europe B.V. NL-AR-000000116
Sources (2)
- EUDAMED 574bd6ee-f9af-4ee1-8f6c-0d211f1a461c 61 fields · synced Aug 5, 2026
- EUDAMED 1b88b6fb-f143-42f3-9de0-f8592609564b 61 fields · synced May 19, 2026