Identity
- Trade Name
- Silicone Head Harness Large EUDAMED
- Device Name
- Reusable Headgear EUDAMED
- Model / Reference
- XTA0001 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06923980111570 EUDAMED
- Basic UDI-DI
- 69239801NR1EARP EUDAMED
- EMDN Code
- R03010180 ARTIFICIAL VENTILATION MASKS - ACCESSORIES EUDAMED
Classification
- Device Class
- Class I 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
Silicone Head Harness Large by GaleMed (Xiamen) Co., Ltd. — Class I — 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 | 69239801NR1EARP | Class I | 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 c21ca93d-c92a-42a7-bae1-7c198a164141 61 fields · synced Jul 23, 2026
- EUDAMED bf606302-8f01-4e8b-b742-2d3823f8cace 61 fields · synced Jul 23, 2026