Identity
- Trade Name
- Spline® EUDAMED
- Device Name
- Non-Sterile Dental Instruments EUDAMED
- Model / Reference
- 2221 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00889024013407 EUDAMED
- Basic UDI-DI
- 844868A8H8 EUDAMED
- EMDN Code
- Q0199 ODONTOLOGY DEVICES - OTHER 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
Spline® by ZimVie US Corp LLC — Class I — MDR — listed in EUDAMED — regulatory data on deviCERTS
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 | 844868A8H8 | 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 765e2e89-4e9c-4dfb-b987-a5e39fa40755 61 fields · synced Jul 21, 2026