Identity
- Trade Name
- help:ex plaque f EUDAMEDFDA UDI
- Generic Name
- Denture cleanser FDA UDI
- Device Name
- help:ex EUDAMEDCleanser for the removal of tartar and plaque on dental prostheses, liquid FDA UDI
- Model / Reference
- 67000100 EUDAMEDFDA UDI
- Description
- Cleanser for the removal of tartar and plaque on dental prostheses, liquid FDA UDI
Identifiers
- Catalog Number
- 67000100 FDA UDI
- Primary DI / UDI-DI
- +J009670001000 EUDAMEDJ009670001000 FDA UDI
- Basic UDI-DI
- ++J00967002U EUDAMED
- Direct Marketing DI
- +J009670001000 EUDAMED
- FDA Product Code
- NUX FDA UDI
- EMDN Code
- V0799 PRODUCTS FOR CLEANING MEDICAL DEVICES NOT INCLUDED IN OTHER CLASSES - OTHER EUDAMED
- GMDN Term
- Denture cleanser FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 872.3520 FDA UDI
- Market of Registration
- Germany EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
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
Yes
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
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
help:ex plaque f by Renfert GmbH — 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
European Union Active
CE/MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | ++J00967002U | Class I | Active |
| EUDAMED | European Union | CE/MDR | ++J00967002U | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Renfert GmbH
- EUDAMED SRN
- DE-MF-000005448
Sources (2)
- EUDAMED a88a6b03-6c6c-45ff-b5d3-c58d02819eb3 61 fields · synced Jun 8, 2026
- FDA UDI a0f6d54e-3fae-40f5-b97d-eb96cee28016 35 fields · synced May 29, 2026