Identity
- Trade Name
- Venti.Plus Hyperinflation Kit, 1.0L EUDAMED
- Device Name
- Disposable Anesthesia Circuit EUDAMED
- Model / Reference
- AR0026 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06923980104480 EUDAMED
- Basic UDI-DI
- 69239801ND2BCNM EUDAMED
- EMDN Code
- R020199 BREATHING CIRCUITS AND KITS - OTHER 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
Venti.Plus Hyperinflation Kit, 1.0L 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 | 69239801ND2BCNM | 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 2be9264c-a1d0-4b00-a165-a4683b3eb206 61 fields · synced Jul 25, 2026