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Breathing Bag, 3L, Latex
EUDAMEDClass IIa (EU MDR)
Ref AB0106Model (I) Anesthesia CircuitRef AB0122
Identity
- Trade Name
- Breathing Bag, 3L, Latex EUDAMEDBreathing Bag, 3L, Latex Free EUDAMED
- Device Name
- Breathing Bag EUDAMED
- Model / Reference
- (I) Anesthesia Circuit EUDAMEDAB0106 EUDAMEDAB0122 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04710810084690 EUDAMED04710810083150 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, 3L, Latex 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 ae622aca-ea6e-4ff9-85c0-e57aab14a197 61 fields · synced Jul 29, 2026
- EUDAMED 0acb5417-be76-403f-b126-10bed897175f 61 fields · synced May 19, 2026