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VOLNEWMER Coupling Gel
EUDAMEDFDA UDIClass I (EU MDR)
Ref XG00-00007-001
by Classys
Identity
- Trade Name
- VOLNEWMER Coupling Gel EUDAMEDCoupling Gel FDA UDI
- Generic Name
- Electrode conductive medium FDA UDI
- Device Name
- Coupling Gel EUDAMED
- Model / Reference
- XG00-00007-001 EUDAMEDXG00-00010-001 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 08800016902792 EUDAMEDFDA UDI
- Basic UDI-DI
- 8800016902792YF EUDAMED
- 510(k) Number
- K240248 FDA UDI
- FDA Product Code
- GEI FDA UDI
- EMDN Code
- V9015 ELECTRODES AND PROBES CUTANEOUS CONDUCTIVE SUBSTANCES EUDAMED
- GMDN Term
- Electrode conductive medium FDA UDI
Classification
- Device Class
- Class I EUDAMEDClass II FDA UDI
- Regulation Number
- 878.4400 FDA UDI
- Market of Registration
- Northern Ireland 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
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
Yes
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
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
VOLNEWMER Coupling Gel by Classys — Class I — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
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 | 8800016902792YF | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Classys
- EUDAMED SRN
- KR-MF-000010116
- Authorised Representative
- Medical Technology Promedt Consulting GmbH DE-AR-000000085
Sources (2)
- EUDAMED 3a92cfa9-7b66-4fc9-a0f1-07eff9320a60 61 fields · synced Jun 19, 2026
- FDA UDI 3a7904a0-b5dd-4b97-b449-e5aef07426f3 33 fields · synced May 30, 2026