Identity
- Trade Name
- GingiTrax Periodent 2 x 2g EUDAMED
- Device Name
- Tooth Preparation Products - Gingival Retraction Pastes EUDAMED
- Model / Reference
- 05 015102 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 05056009107603 EUDAMED
- Basic UDI-DI
- 5056009120046SB EUDAMED
- EMDN Code
- Q010204 RETRACTION WIRES AND GINGIVAL RETRACTORS 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
Category: Gingival retraction cord, non-medicated
GingiTrax Periodent 2 x 2g by Advanced Healthcare Ltd. — Class I — MDR — listed in EUDAMED — regulatory data on deviCERTS
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Also classified as Gingival retraction cord, non-medicated.
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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 | 5056009120046SB | 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 fdda310c-5192-4bfe-b678-d217dd32a6ea 61 fields · synced Sep 18, 2026