Identity
- Trade Name
- AiD Regen EUDAMEDFDA UDI
- Generic Name
- CAD/CAM software FDA UDI
- Device Name
- AiD Regen EUDAMED
- Model / Reference
- AIDR-001 EUDAMEDFDA UDI
Identifiers
- Primary DI / UDI-DI
- 08809692507000 EUDAMEDFDA UDI
- Basic UDI-DI
- 880969250AIDR001P5 EUDAMED
- Direct Marketing DI
- 08809692507000 EUDAMED
- FDA Product Code
- OUG FDA UDI
- EMDN Code
- V92 MEDICAL DEVICE SOFTWARE - NOT INCLUDED IN OTHER CLASSES EUDAMED
- GMDN Term
- CAD/CAM software FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 880.6310 FDA UDI
- Market of Registration
- Türkiye EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
No
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
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
Prescription Use
No
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
Yes
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
AiD Regen by Rokit Healthcare Inc. — Class I — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 880969250AIDR001P5 | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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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 838d6fb3-8601-4139-8db8-097ee7769e1d 61 fields · synced Jul 21, 2026
- FDA UDI a5e0d5e3-00e9-49c8-981a-1bbe51486cc0 32 fields · synced May 30, 2026