Identity
- Trade Name
- Hardik EUDAMED
- Device Name
- 1.5mm Cortex Screws 13mm, SS 316L EUDAMED
- Model / Reference
- 1.5mm Cortex Screws 13mm EUDAMEDT001.13 EUDAMED
Identifiers
- Primary DI / UDI-DI
- G648T001130 EUDAMED
- Basic UDI-DI
- B-G648T001130 EUDAMED
- EMDN Code
- P09120699 BONE FIXATION SCREWS, TENDON AND LIGAMENT SYNTHESIS SCREWS - 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
Hardik by Hardik International 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-G648T001130 | Class IIb | Active |
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Manufacturer
- Manufacturer
- Hardik International Private Limited
- EUDAMED SRN
- IN-MF-000007251
- Authorised Representative
- Meddevices Lifesciences B.V. NL-AR-000000594
Sources (1)
- EUDAMED 9efb1f00-e270-4ace-91ad-99cf17433a9b 61 fields · synced Jun 18, 2026