Identity
- Trade Name
- Neo ADVISE FDA UDI
- Generic Name
- Spinal rod bending system FDA UDI
- Device Name
- Neo ADVISE EUDAMED
- Model / Reference
- R2 EUDAMEDR2.X.Y FDA UDI
Identifiers
- Primary DI / UDI-DI
- 07649994217013 EUDAMEDFDA UDI
- Basic UDI-DI
- 7649994217013R25X EUDAMED
- 510(k) Number
- K230195 FDA UDI
- FDA Product Code
- OLO FDA UDI
- EMDN Code
- Z11069001 BIOIMAGING PROCESSORS EUDAMED
- GMDN Term
- Spinal rod bending system FDA UDI
Classification
- Device Class
- Class I EUDAMEDClass II FDA UDI
- Regulation Number
- 882.4560 FDA UDI
- Special Device Type
- Software EUDAMED
- Market of Registration
- Germany 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
Yes
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Prescription Use
Yes
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
No
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Neo ADVISE by Comerge AG — 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 | 7649994217013R25X | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Comerge AG
- EUDAMED SRN
- CH-MF-000029069
- Authorised Representative
- Medical Technology Promedt Consulting GmbH DE-AR-000000085
Sources (2)
- EUDAMED d513b454-298d-4d8f-a0bc-20ed5c80ed5d 61 fields · synced May 30, 2026
- FDA UDI a78516c1-ce4b-4d06-b392-4dde444149ed 33 fields · synced May 30, 2026