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Sorath Ortho, Sorath
EUDAMEDClass IIb (EU MDR)
Ref C04813007Model Twin Lock-BCP L Buttress Plate, Left, 07 Holes, SS316LVM
Identity
- Trade Name
- Sorath Ortho, Sorath EUDAMED
- Model / Reference
- Twin Lock-BCP L Buttress Plate, Left, 07 Holes, SS316LVM EUDAMEDC04813007 EUDAMED
Identifiers
- Primary DI / UDI-DI
- G500C048130070 EUDAMED
- Basic UDI-DI
- B-G500C048130070 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 Ortho, Sorath 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-G500C048130070 | 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 c50caf5b-cba5-457c-9c15-2d63d39e1373 61 fields · synced Jun 18, 2026