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Sterile powered surgically invasive instrument
EUDAMEDClass IIa (EU MDR)
Ref ZOPTT30
Identity
- Device Name
- Sterile powered surgically invasive instrument EUDAMED
- Model / Reference
- ZOPTT30 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00889024021433 EUDAMED
- Basic UDI-DI
- 844868AFJ2 EUDAMED
- EMDN Code
- L159099 ODONTOSTOMATOLOGY INSTRUMENTS, REUSABLE - OTHER EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Spain EUDAMED
Clinical & Handling
Sterile
Yes
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
Sterile powered surgically invasive instrument by ZimVie US Corp LLC — Class IIa — 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 | 844868AFJ2 | Class IIa | 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 4a861a05-4450-4b7a-8ed4-fd6f283fa771 61 fields · synced Jul 25, 2026