Identity
- Trade Name
- Mucopren Adhesive EUDAMEDMucopren FDA UDI
- Generic Name
- Denture reliner, elastic, long-term FDA UDI
- Device Name
- Mucopren Adhesive EUDAMEDFDA UDI
- Model / Reference
- 14203 EUDAMEDFDA UDI
- Description
- Mucopren Adhesive FDA UDI
Identifiers
- Catalog Number
- 14203 FDA UDI
- Primary DI / UDI-DI
- E217142031 EUDAMEDFDA UDI
- Basic UDI-DI
- ++E217RELADHXH EUDAMED
- 510(k) Number
- K983357 FDA UDI
- FDA Product Code
- EBI FDA UDI
- EMDN Code
- Q0199 ODONTOLOGY DEVICES - OTHER EUDAMED
- GMDN Term
- Denture reliner, elastic, long-term FDA UDI
Classification
- Device Class
- Class I EUDAMEDClass II FDA UDI
- Regulation Number
- 872.3760 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
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Mucopren Adhesive by Kettenbach GmbH & Co. KG — 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 | ++E217RELADHXH | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Kettenbach GmbH & Co. KG
- EUDAMED SRN
- DE-MF-000005014
Sources (2)
- EUDAMED 6c43b2c0-c827-4a70-957c-3653122181ca 61 fields · synced Oct 6, 2026
- FDA UDI 91215ccf-b4d2-48ce-894a-778051e36953 37 fields · synced May 30, 2026