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proKlene Regular Prophylaxis Paste Coarse Orange 250g
EUDAMEDClass I (EU MDR)
Ref AH1400-H
Identity
- Trade Name
- proKlene Regular Prophylaxis Paste Coarse Orange 250g EUDAMED
- Device Name
- Oral Hygiene Products - Prophylaxis pastes EUDAMED
- Model / Reference
- AH1400-H EUDAMED
Identifiers
- Primary DI / UDI-DI
- 05056009112287 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 Regular Prophylaxis Paste Coarse 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 (1)
- EUDAMED b23eda56-b7cc-461a-8ee6-41bf2fc93638 61 fields · synced Jun 18, 2026