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Endoscope Valves Set
EUDAMEDClass I (EU MDR)
Ref U7101-FRef U7000-ORef U7101-ORef U7000-FRef U7100-FRef U7001-F
Identity
- Trade Name
- Endoscope Valves Set EUDAMED
- Device Name
- Endoscope Valves Set EUDAMED
- Model / Reference
- U7101-F EUDAMEDU7000-O EUDAMEDU7101-O EUDAMEDU7000-F EUDAMEDU7100-F EUDAMEDU7001-F EUDAMED
Identifiers
- Primary DI / UDI-DI
- 05420051307715 EUDAMED05420051303366 EUDAMED05420051307647 EUDAMED05420051306657 EUDAMED05420051307685 EUDAMED05420051306664 EUDAMED
- Basic UDI-DI
- 54200513-TF22-EVL-SU-FY EUDAMED
- EMDN Code
- G0380 DIGESTIVE ENDOSCOPY DEVICES - ACCESSORIES EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Belgium EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
Reprocessed
Yes
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
Category: Gastro-urological guidewire, single-use
Endoscope Valves Set by G-Flex Flexible Instruments Europe — Class I — MDR — listed in EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as Gastro-urological guidewire, single-use.
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- Führungsdraht, "Grip-Wire", Nitinol — MTW - Endoskopie W. Haag KG · Class IIa
- Disposable Endoscopy Adapter Set — Yangzhou Fartley Medical Instrument Technology Co., Ltd. · Class I
- Optimos™ Guidewire — Taewoong Medical · Class II
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 | 54200513-TF22-EVL-SU-FY | Class I | Active |
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Manufacturer
- Manufacturer
- G-Flex Flexible Instruments Europe
- EUDAMED SRN
- BE-MF-000000623
Sources (6)
- EUDAMED 53918488-8ab0-4e88-96a3-db27be0cab27 61 fields · synced Aug 1, 2026
- EUDAMED c406da77-4ea4-42a1-a99b-55536f9a0b48 61 fields · synced May 17, 2026
- EUDAMED 1d6c4779-1955-48c4-88be-0fb84a7f4131 61 fields · synced May 18, 2026
- EUDAMED 2f227b0a-f568-4d04-be8a-88c31d44d39a 61 fields · synced May 18, 2026
- EUDAMED 345bd7cf-7fe9-442f-8168-0c0e5a46c43d 61 fields · synced May 19, 2026
- EUDAMED 7a139b80-c37b-46ff-bab6-396bf75eb997 61 fields · synced May 19, 2026