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Dr. INVIVO AI Regen KIT
EUDAMEDClass IIa (EU MDR)
Ref ARK-002Model ARK-001, ARK-002Ref ARK-001
Identity
- Trade Name
- Dr. INVIVO AI Regen KIT EUDAMED
- Device Name
- Dr. INVIVO AI Regen KIT EUDAMED
- Model / Reference
- ARK-001, ARK-002 EUDAMEDARK-002 EUDAMEDARK-001 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08809692500186 EUDAMED08809692500063 EUDAMED
- Basic UDI-DI
- 880969250DrINVIVOARKVJ EUDAMED
- Direct Marketing DI
- 08809692500186 EUDAMED08809692500063 EUDAMED
- EMDN Code
- V901601 PLASTIC SURGERY AND NON-AESTHETIC PURPOSES GENERIC USE INSTRUMENTS AND KITS, SINGLE-USE EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Türkiye EUDAMED
Clinical & Handling
Sterile
Yes
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 AI Regen KIT by Rokit Healthcare Inc. — 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 | 880969250DrINVIVOARKVJ | Class IIa | 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 (2)
- EUDAMED a3d83937-9c21-49bf-86bb-71f309f9d0a9 61 fields · synced Jul 13, 2026
- EUDAMED 72c4ecd8-1f0e-4936-a8a6-b13b7c610ba7 61 fields · synced May 18, 2026