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Sorath, Sorath Ortho
EUDAMEDClass IIb (EU MDR)
Ref E15404210Model HybridLock Humerus Nail, Cannulated, Dia. 6.0 mm, 210 mm, Titanium G23
Identity
- Trade Name
- Sorath, Sorath Ortho EUDAMED
- Model / Reference
- HybridLock Humerus Nail, Cannulated, Dia. 6.0 mm, 210 mm, Titanium G23 EUDAMEDE15404210 EUDAMED
Identifiers
- Primary DI / UDI-DI
- G500E154042100 EUDAMED
- Basic UDI-DI
- B-G500E154042100 EUDAMED
- EMDN Code
- P09120299 OSTEOSYNTHESIS NAILS - 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
Sorath, Sorath Ortho by Sigma Surgical Private Limited — Class IIb — MDD — listed in EUDAMED — regulatory data on deviCERTS
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-G500E154042100 | 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 59d693b0-eda9-4452-8d24-e8f4409fe2a4 61 fields · synced Jun 19, 2026