Identity
- Trade Name
- Adj. PEEP Valve, 5~20cmH2O EUDAMED
- Device Name
- Disposable PEEP VALVE EUDAMED
- Model / Reference
- AV0002 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06923980104657 EUDAMED
- Basic UDI-DI
- 69239801ND2OAPQ EUDAMED
- EMDN Code
- R030280 RESPIRATORY BALLONS - ACCESSORIES EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Italy 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
Adj. PEEP Valve, 5~20cmH2O 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 (1)
- EUDAMED 878fdf0a-33bc-47f0-8506-0d6b08569e6e 61 fields · synced Jun 18, 2026