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Sorath, Sorath Ortho
EUDAMEDClass IIb (EU MDR)
Ref G00504065Model Spiked Washer
Identity
- Trade Name
- SORATH, SORATH ORTHO EUDAMED
- Device Name
- Spinal Implants EUDAMED
- Model / Reference
- Spiked Washer EUDAMEDG00504065 EUDAMED
Identifiers
- Primary DI / UDI-DI
- G500G005040650 EUDAMED
- Basic UDI-DI
- B-G500G005040650 EUDAMED
- EMDN Code
- P09120201 INTRAMEDULLARY NAILS 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: Arthrodesis intramedullary nail, non-distracting
Sorath, Sorath Ortho by Sigma Surgical Private Limited — Class IIb — MDD — listed in EUDAMED — regulatory data on deviCERTS
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Also classified as Arthrodesis intramedullary nail, non-distracting.
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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-G500G005040650 | 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 7a29b7d7-6081-459e-b702-a32f2624f459 61 fields · synced Jun 18, 2026