Identity
- Trade Name
- EVA Circuit, Adult EUDAMED
- Device Name
- Disposable Ventilation Circuit EUDAMED
- Model / Reference
- AB0329 EUDAMEDAB0234 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06923980103568 EUDAMED06923980104855 EUDAMED
- Basic UDI-DI
- 69239801ND2SBQ6 EUDAMED
- EMDN Code
- R02010102 BREATHING CIRCUITS, WITH WATER TRAP 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
EVA Circuit, Adult 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 | 69239801ND2SBQ6 | Class IIa | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- GaleMed (Xiamen) Co., Ltd.
- EUDAMED SRN
- CN-MF-000020627
- Authorised Representative
- Emergo Europe B.V. NL-AR-000000116
Sources (2)
- EUDAMED 8886685b-5afb-4716-9ce6-48b8743b6c0b 61 fields · synced Jul 16, 2026
- EUDAMED f410cab0-0d30-44d4-9e84-9a9c4173dbcc 61 fields · synced May 19, 2026