Identity
- Trade Name
- Dr. INVIVO EUDAMED
- Device Name
- Dr. INVIVO EUDAMED
- Model / Reference
- 4D2D100 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08809692501008 EUDAMED
- Basic UDI-DI
- 880969250DRINVIVOPZ EUDAMED
- Direct Marketing DI
- 08809692501008 EUDAMED
- EMDN Code
- Z12019003 WOUND TREATMENT EQUIPMENT EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Türkiye 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
Dr. INVIVO by Rokit Healthcare Inc. — 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 | 880969250DRINVIVOPZ | Class I | Active |
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Manufacturer
- Manufacturer
- ROKIT HEALTHCARE Inc.
- EUDAMED SRN
- KR-MF-000009720
- Authorised Representative
- AR Experts B.V. NL-AR-000023989
Sources (1)
- EUDAMED 675bbddf-0103-40a2-869d-ac6aa4463748 61 fields · synced Jul 12, 2026