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AstrinGIVAL Hemostatic Gingival Retraction Paste 2x2g
EUDAMEDClass I (EU MDR)
Ref WDAH1650Ref AH1650Ref AH1650-H
Identity
- Trade Name
- AstrinGIVAL Hemostatic Gingival Retraction Paste 2x2g EUDAMEDAstrinGIVAL Hemostatic Gingival Retraction Paste EUDAMED
- Device Name
- Tooth Preparation Products - Gingival Retraction Pastes EUDAMED
- Model / Reference
- WDAH1650 EUDAMEDAH1650 EUDAMEDAH1650-H EUDAMED
Identifiers
- Primary DI / UDI-DI
- 05060446608975 EUDAMED05060446608456 EUDAMED05056009112331 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
AstrinGIVAL Hemostatic Gingival Retraction Paste 2x2g 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 (3)
- EUDAMED 8849a729-cb6a-4bfc-b2a9-7bda650a32a1 61 fields · synced Aug 3, 2026
- EUDAMED d723fbe1-19a0-4ba8-9b9c-b500cb64838c 61 fields · synced May 17, 2026
- EUDAMED 64365500-79c0-46ae-8695-6fa80d477af3 61 fields · synced May 19, 2026