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Medical Flow Meter For Terminal Units of Medical Gas Pipe System
EUDAMEDFDA UDIClass IIa (EU MDR)
Ref DESF-03Model FM197A-1L FM197A-3L FM197A-6L FM197A-15L FM197A-30L FM197A-50L FM197A-70L,FM197B-1L,FM197B-3L,FM197B-6L,FM197B-15L,FM197B-30L,FM197B-50L,FM197B-70LRef FM197A-3LModel 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, 3L Series, Oxygen or Air, Aluminum FDA UDI
- Model / Reference
- FM197A-1L FM197A-3L FM197A-6L FM197A-15L FM197A-30L FM197A-50L FM197A-70L,FM197B-1L,FM197B-3L,FM197B-6L,FM197B-15L,FM197B-30L,FM197B-50L,FM197B-70L EUDAMEDDESF-03 EUDAMEDFM197A-3L EUDAMEDFDA UDIFM197A-15L EUDAMED
- Description
- Flowmeter, 3L Series, Oxygen or Air, Aluminum FDA UDI
Identifiers
- Primary DI / UDI-DI
- 06970966664506 EUDAMEDFDA UDI
- Basic UDI-DI
- B-06970966664506 EUDAMED6970966660010DS 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 EUDAMEDFrance 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
Yes
EUDAMEDEUDAMED
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, MDD, FDA UDI — listed in EUDAMED, FDA GUDID
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDR
European Union Active
CE/MDD
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | B-06970966664506 | Class IIa | Active |
| EUDAMED | European Union | CE/MDD | B-06970966664506 | 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 GmbH DE-AR-000000002
Sources (3)
- EUDAMED 03354e0a-6996-4cd4-a238-3c192df198d2 61 fields · synced Oct 6, 2026
- FDA UDI a98511b3-3b2e-42a0-9d59-e0b607b6ec96 34 fields · synced May 30, 2026
- EUDAMED a2ac30c6-8303-4c42-a917-f246d1e951e4 61 fields · synced Jul 13, 2026