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Silicone Breathing Bag, 1L w/Loop End
EUDAMEDClass IIa (EU MDR)
Ref AB0108Model (I) Anesthesia Circuit
Identity
- Trade Name
- Silicone Breathing Bag, 1L w/Loop End EUDAMED
- Device Name
- Disposable Breathing bag EUDAMEDReusable Breathing Bag EUDAMED
- Model / Reference
- AB0108 EUDAMED(I) Anesthesia Circuit EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06923980112362 EUDAMED04710810082399 EUDAMED
- Basic UDI-DI
- 69239801ND2CANL EUDAMED471081008RNI38K EUDAMED
- Direct Marketing DI
- 04710810082399 EUDAMED
- EMDN Code
- R028099 RESPIRATORY CIRCUITS AND MOUNT CATHETERS - ACCESSORIES NOT INCLUDED IN OTHER CLASSES EUDAMEDR02010101 BREATHING CIRCUITS, W/O WATER TRAP EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Denmark EUDAMEDNetherlands 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, 1L w/Loop End 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 (2)
- EUDAMED 40a24406-d7e4-4389-b85d-70924d15946e 61 fields · synced Jul 13, 2026
- EUDAMED d9e86a65-b786-486f-b375-2070889b0f95 61 fields · synced Jul 13, 2026