Identity
- Trade Name
- MR-100 Reservoir Bag, 600ml EUDAMED
- Device Name
- Disposable Breathing bag EUDAMED
- Model / Reference
- AR0020 EUDAMEDAR0019 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06923980105319 EUDAMED06923980100147 EUDAMED
- Basic UDI-DI
- 69239801ND2CCNQ 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
- Germany 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
MR-100 Reservoir Bag, 600ml 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 | 69239801ND2CCNQ | 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 5f7a54fc-f843-4181-96e1-7d758fb2ec11 61 fields · synced Jul 15, 2026
- EUDAMED 9421bd5a-7ff7-4475-a258-8a2f61824c48 61 fields · synced May 18, 2026