Identity
- Device Name
- Reusable Surgical Dental Instruments EUDAMED
- Model / Reference
- OST00 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00844868038207 EUDAMED
- Basic UDI-DI
- 844868A1GS EUDAMED
- EMDN Code
- L150103 DENTAL OSTEOTOME BLADES, REUSABLE EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Spain EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
Yes
EUDAMED
Contains Latex
No
EUDAMED
Reprocessed
No
EUDAMED
CMR Substance
Yes
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: Dental osteotome
Reusable Surgical Dental Instruments by ZimVie US Corp LLC — Class I — MDR — listed in EUDAMED — regulatory data on deviCERTS
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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 | 844868A1GS | Class I | Active |
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Manufacturer
- Manufacturer
- ZimVie US Corp LLC
- EUDAMED SRN
- US-MF-000048255
- Authorised Representative
- ZimVie Spain S.L.U. ES-AR-000000983
Sources (1)
- EUDAMED 54ef23d5-f341-4e33-8efb-9f8173a23565 61 fields · synced Jul 26, 2026