Identity
- Trade Name
- OrthAlign Plus EUDAMEDFDA UDI
- Generic Name
- Orthopaedic stereotactic surgery system FDA UDI
- Device Name
- OrthAlign Plus Unit EUDAMEDOrthAlign Plus Unit - P3 FDA UDI
- Model / Reference
- 403001 EUDAMED403001-07 EUDAMEDFDA UDI
- Description
- OrthAlign Plus Unit - P3 FDA UDI
Identifiers
- Catalog Number
- 403001-07 FDA UDI
- Primary DI / UDI-DI
- 00810832031352 EUDAMEDFDA UDI
- Basic UDI-DI
- B-00810832031352 EUDAMED
- FDA Product Code
- OLO FDA UDI
- EMDN Code
- V0380 DEVICES WITH MEASURING FUNCTIONS - ACCESSORIES EUDAMED
- GMDN Term
- Orthopaedic stereotactic surgery system FDA UDI
Classification
- Device Class
- Class I EUDAMEDClass II FDA UDI
- Regulation Number
- 882.4560 FDA UDI
- Market of Registration
- Italy EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
EUDAMEDFDA UDI
Single Use
Yes
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
Reprocessed
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
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
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
OrthAlign Plus by Orthalign, Inc. — Class I — MDD, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDD
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | B-00810832031352 | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- OrthAlign, Inc
- EUDAMED SRN
- US-MF-000027362
- Authorised Representative
- MDSS GmbH DE-AR-000005430
Sources (2)
- EUDAMED 8239aa81-b353-41e6-a625-f7d9481f20f9 61 fields · synced May 30, 2026
- FDA UDI 8b525e69-6521-49ac-a4ce-494652647861 36 fields · synced May 30, 2026