Identity
- Trade Name
- Disposable Adjustable EUDAMED
- Device Name
- Disposable PEEP VALVE EUDAMED
- Model / Reference
- XTA0010 EUDAMEDXTA0125 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06923980109850 EUDAMED06923980110146 EUDAMED
- Basic UDI-DI
- 69239801ND2OAPQ EUDAMED
- EMDN Code
- R030280 RESPIRATORY BALLONS - ACCESSORIES 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
Disposable Adjustable 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 | 69239801ND2OAPQ | 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 9fbbc7ae-ec74-4148-80e8-1b1f9a4e3ede 61 fields · synced Jul 13, 2026
- EUDAMED f03401de-d248-4c11-a97c-752aac8fd099 61 fields · synced May 17, 2026