Identity
- Trade Name
- VAL1-G7-50 EUDAMEDFUJIFILM medwork FDA UDI
- Generic Name
- Endoscope working-channel valve, single-use FDA UDI
- Device Name
- VAL1-G7-Series EUDAMED
- Model / Reference
- 70100146737 EUDAMEDVAL1-G7-50 FDA UDI
Identifiers
- Catalog Number
- VAL1-G7-50 FDA UDI
- Primary DI / UDI-DI
- 04044503055828 EUDAMEDFDA UDI
- Basic UDI-DI
- 4044503056624D EUDAMED
- 510(k) Number
- K210625 FDA UDI
- FDA Product Code
- ODC FDA UDIFDF FDA UDI
- EMDN Code
- G0380 DIGESTIVE ENDOSCOPY DEVICES - ACCESSORIES EUDAMED
- GMDN Term
- Endoscope working-channel valve, single-use FDA UDI
Classification
- Device Class
- Class I EUDAMEDClass II FDA UDI
- Regulation Number
- 876.1500 FDA UDI
- Market of Registration
- Germany EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
EUDAMEDFDA UDI
Single Use
Yes
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
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Gastro-urological guidewire, single-use
Val1-G7-50 by FUJIFILM medwork GmbH — Class I — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
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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 | 4044503056624D | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- FUJIFILM medwork GmbH
- EUDAMED SRN
- DE-MF-000008444
Sources (2)
- EUDAMED cde4feaa-c6da-4021-b936-40db1f6e4573 61 fields · synced Aug 5, 2026
- FDA UDI f9ad0083-51fb-48c9-8459-a017d3fb514e 35 fields · synced May 30, 2026