Identity
- Trade Name
- KemKat Impression Composition Box/7 EUDAMED
- Device Name
- Dental Impression Composition EUDAMED
- Model / Reference
- COM611 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 05021752000396 EUDAMED
- Basic UDI-DI
- 5021752COMPO06347997G EUDAMED
- EMDN Code
- Q010699 MATERIALS FOR THE PREPARATION OF CUSTOM-MADE DENTAL DEVICES - OTHER EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Ireland EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
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
KemKat Impression Composition Box/7 by Associated Dental Products Ltd — Class I — MDR — listed in EUDAMED — regulatory data on deviCERTS
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 | 5021752COMPO06347997G | Class I | Active |
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Manufacturer
- Manufacturer
- Associated Dental Products Ltd
- EUDAMED SRN
- GB-MF-000003673
- Authorised Representative
- Kemdent Limited IE-AR-000001930
Sources (1)
- EUDAMED 354c02ba-712b-4145-90ff-fc9e70ef198b 61 fields · synced Jun 19, 2026