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Medical Flow Meter For Terminal Units of Medical Gas Pipe System
EUDAMEDClass IIa (EU MDR)
Ref FM197B-15LModel FM197A-15L
Identity
- Trade Name
- Medical Flow Meter For Terminal Units of Medical Gas Pipe System EUDAMED
- Device Name
- Medical Flow Meter For Terminal Units of Medical Gas Pipe System EUDAMED
- Model / Reference
- FM197A-15L EUDAMEDFM197B-15L EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06970966660164 EUDAMED
- Basic UDI-DI
- 6970966660010DS EUDAMED
- EMDN Code
- A030104 FLOW REGULATORS EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- France 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
Medical Flow Meter For Terminal Units of Medical Gas Pipe System by Gentec (shanghai) Corporation — Class IIa — MDR — listed in EUDAMED
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 | 6970966660010DS | Class IIa | Active |
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Manufacturer
- Manufacturer
- Gentec (Shanghai) Corporation
- EUDAMED SRN
- CN-MF-000012841
- Authorised Representative
- MedNet EC-REP C IIb GmbH DE-AR-000011194
Sources (1)
- EUDAMED 2c7f0ca7-ddfc-4f8f-8d43-cdaf5bb5d170 61 fields · synced Jun 19, 2026