Identity
- Trade Name
- HC Norman Mask Elbow (22M/15F-15M EUDAMED
- Device Name
- Disposable Connector EUDAMED
- Model / Reference
- XTA0138 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06923980109607 EUDAMED
- Basic UDI-DI
- 69239801ND2GANY EUDAMED
- EMDN Code
- R020302 RESPIRATORY CIRCUITS ADAPTERS AND CONNECTORS 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
HC Norman Mask Elbow (22M/15F-15M 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 | 69239801ND2GANY | 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 9606d2dd-6d88-4919-a52f-c3ea184181fd 61 fields · synced Jul 15, 2026