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Medical Flow Meter For Terminal Units of Medical Gas Pipe System
EUDAMEDFDA UDIClass IIa (EU MDR)
Ref FM197A-15L
Identity
- Trade Name
- Medical Flow Meter For Terminal Units of Medical Gas Pipe System EUDAMEDGENTEC® FDA UDI
- Generic Name
- Medical gas flowmeter, Thorpe tube FDA UDI
- Device Name
- Medical Flow Meter For Terminal Units of Medical Gas Pipe System EUDAMEDFlowmeter, 15L Series, Oxygen or Air, Aluminum FDA UDI
- Model / Reference
- FM197A-15L EUDAMEDFDA UDI
- Description
- Flowmeter, 15L Series, Oxygen or Air, Aluminum FDA UDI
Identifiers
- Primary DI / UDI-DI
- 06970966660140 EUDAMEDFDA UDI
- Basic UDI-DI
- 6970966660010DS EUDAMED
- FDA Product Code
- CAX FDA UDI
- EMDN Code
- A030104 FLOW REGULATORS EUDAMED
- GMDN Term
- Medical gas flowmeter, Thorpe tube FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass I FDA UDI
- Regulation Number
- 868.2340 FDA UDI
- Market of Registration
- Germany EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
No
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
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
Prescription Use
No
FDA UDI
Over-the-Counter
Yes
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
Yes
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Medical Flow Meter For Terminal Units of Medical Gas Pipe System by Gentec (shanghai) Corporation — Class IIa — MDR, FDA UDI — listed in EUDAMED, FDA GUDID
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 6970966660010DS | Class IIa | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIa | Pending data |
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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 (2)
- EUDAMED 76b8da55-ecd6-4665-b987-51b7ecbbfd97 61 fields · synced Oct 6, 2026
- FDA UDI 5d720289-cb9a-49a7-83e7-12be1c672e90 34 fields · synced May 30, 2026