Identity
- Trade Name
- MHC One Way Valve (Bulk Package) EUDAMED
- Device Name
- Disposable Valve & Manifold EUDAMED
- Model / Reference
- XTA0037 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 46923980110403 EUDAMED
- Basic UDI-DI
- 69239801ND2RDQ7 EUDAMED
- EMDN Code
- R028001 RESPIRATORY CIRCUITS VALVES 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
MHC One Way Valve (Bulk Package) 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 | 69239801ND2RDQ7 | 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 (1)
- EUDAMED d1b8e574-b357-4fe8-b263-5efedf865146 61 fields · synced Jun 19, 2026