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Silicone Breathing Bag, 0.5L w/Loop End
EUDAMEDClass IIa (EU MDR)
Ref AB0107Model (I) Anesthesia Circuit
Identity
- Trade Name
- Silicone Breathing Bag, 0.5L w/Loop End EUDAMED
- Device Name
- Reusable Breathing Bag EUDAMED
- Model / Reference
- (I) Anesthesia Circuit EUDAMEDAB0107 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04710810084881 EUDAMED
- Basic UDI-DI
- 471081008RNI38K EUDAMED
- Direct Marketing DI
- 04710810084881 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
Silicone Breathing Bag, 0.5L w/Loop End 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 | 471081008RNI38K | 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 (1)
- EUDAMED 511a99ab-dc0b-468f-b356-4e96df8299e5 61 fields · synced Jun 19, 2026