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proKlene+ Oil Free Prophylaxis Paste Medium Orange 250g
EUDAMEDClass I (EU MDR)
Ref AH1451-TRef AH1451
Identity
- Trade Name
- proKlene+ Oil Free Prophylaxis Paste Medium Orange 250g EUDAMED
- Device Name
- Oral Hygiene Products - Prophylaxis pastes EUDAMED
- Model / Reference
- AH1451-T EUDAMEDAH1451 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 05060446607770 EUDAMED05060446607305 EUDAMED
- Basic UDI-DI
- 5056009120039SE EUDAMED
- EMDN Code
- Q01010403 DENTAL ABRASIVE AND POLISHING MATERIALS EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Malta 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
proKlene+ Oil Free Prophylaxis Paste Medium Orange 250g by Advanced Healthcare 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 | 5056009120039SE | Class I | Active |
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Manufacturer
- Manufacturer
- Advanced Healthcare Ltd.
- EUDAMED SRN
- GB-MF-000002771
- Authorised Representative
- Advena Limited MT-AR-000000234
Sources (2)
- EUDAMED 0109f72d-9015-4256-b788-a569a3616215 61 fields · synced Aug 1, 2026
- EUDAMED 1c54b84a-8ece-4232-a26a-7a6b0c55f43a 61 fields · synced May 18, 2026