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proKlene Regular Prophylaxis Paste Coarse Orange 50g

EUDAMED

Class I (EU MDR)

Ref WDAH1425Ref AH1425Ref AH1425-TRef AH1425-P

by Advanced Healthcare Ltd.

Identity

Trade Name
proKlene Regular Prophylaxis Paste Coarse Orange 50g EUDAMED
Device Name
Oral Hygiene Products - Prophylaxis pastes EUDAMED
Model / Reference
WDAH1425 EUDAMED
AH1425 EUDAMED
AH1425-T EUDAMED
AH1425-P EUDAMED

Identifiers

Primary DI / UDI-DI
05060446608777 EUDAMED
05060446607039 EUDAMED
05060446609149 EUDAMED
05060446609996 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 50g 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

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Manufacturer

Manufacturer
Advanced Healthcare Ltd.
EUDAMED SRN
GB-MF-000002771
Authorised Representative
Advena Limited MT-AR-000000234

Sources (4)

  • EUDAMED 2fac5dea-6f8c-4b63-bbe2-807cf9d54d2d 61 fields · synced Jul 25, 2026
  • EUDAMED 491fe3d1-b50e-4d4f-9257-7d1bdc3efbbf 61 fields · synced May 17, 2026
  • EUDAMED e4281c48-fe93-4a57-99a8-aa9d14ab3dae 61 fields · synced May 17, 2026
  • EUDAMED 0cea82a3-b557-45bd-9fc6-e5f3a2b75be7 61 fields · synced May 19, 2026