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Sorath, Sorath Ortho
EUDAMEDClass IIb (EU MDR)
Ref C04821010Model Twin Lock-BCP L Buttress Plate, Right, 10 Holes, SS316L
Identity
- Trade Name
- Sorath, Sorath Ortho EUDAMED
- Model / Reference
- Twin Lock-BCP L Buttress Plate, Right, 10 Holes, SS316L EUDAMEDC04821010 EUDAMED
Identifiers
- Primary DI / UDI-DI
- G500C048210100 EUDAMED
- Basic UDI-DI
- B-G500C048210100 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-G500C048210100 | 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 cc62815a-6a6d-44e1-9df0-f4fbcb2c6bba 61 fields · synced Jun 18, 2026