Identity
- Trade Name
- SORATH, SORATH ORTHO EUDAMED
- Device Name
- BONE PLATES EUDAMED
- Model / Reference
- C08714004 EUDAMED
Identifiers
- Primary DI / UDI-DI
- G500C087140040 EUDAMED
- Basic UDI-DI
- B-G500C087140040 EUDAMED
- EMDN Code
- P09120599 BONE FIXATION PLATES - OTHER EUDAMED
Classification
- Device Class
- Class IIb EUDAMED
- Market of Registration
- Bulgaria EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
Yes
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
Reprocessed
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Category: Orthopaedic fixation plate, non-bioabsorbable
Sorath, Sorath Ortho by Sigma Surgical Private Limited — Class IIb — MDD — listed in EUDAMED — regulatory data on deviCERTS
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Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | B-G500C087140040 | Class IIb | Active |
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Manufacturer
- Manufacturer
- Sigma Surgical Private Limited
- EUDAMED SRN
- IN-MF-000013665
- Authorised Representative
- Amstermed B.V. NL-AR-000001971
Sources (1)
- EUDAMED d4081688-7fe1-4f22-92bb-6e3798916ef2 61 fields · synced Jun 18, 2026