Identity
- Device Name
- ORBAT sensitive EUDAMED
- Model / Reference
- 0032327 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 111669979879 EUDAMED
- Basic UDI-DI
- B-111669979879 EUDAMED
- EMDN Code
- Q010204 RETRACTION WIRES AND GINGIVAL RETRACTORS EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Germany EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
Reprocessed
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Category: Gingival retraction cord, non-medicated
ORBAT sensitive by lege artis Pharma GmbH + Co. KG — Class I — MDD — listed in EUDAMED — regulatory data on deviCERTS
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Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | B-111669979879 | Class I | Active |
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Manufacturer
- Manufacturer
- lege artis Pharma GmbH + Co. KG
- EUDAMED SRN
- DE-MF-000006175
Sources (1)
- EUDAMED f26d0f58-dca2-4f10-ba95-8a7d76df0adf 61 fields · synced Oct 6, 2026