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Hardik
EUDAMEDClass IIb (EU MDR)
Ref T001.07Model 1.5mm Cortex Screws 7mmRef T001.14Model 1.5mm Cortex Screws 14mmRef T001.15Model 1.5mm Cortex Screws 15mmRef T001.10Model 1.5mm Cortex Screws 10mmRef T001.08Model 1.5mm Cortex Screws 8mmRef T001.12Model 1.5mm Cortex Screws 12mmRef T001.06Model 1.5mm Cortex Screws 6mmRef T001.05Model 1.5mm Cortex Screws 5mm
Identity
- Trade Name
- Hardik EUDAMED
- Device Name
- 1.5mm Cortex Screws 7mm, SS 316L EUDAMED1.5mm Cortex Screws 14mm, SS 316L EUDAMED1.5mm Cortex Screws 15mm, SS 316L EUDAMED1.5mm Cortex Screws 10mm EUDAMED1.5mm Cortex Screws 8mm, SS 316L EUDAMED1.5mm Cortex Screws 12mm, SS 316L EUDAMED1.5mm Cortex Screws 6mm, SS 316 L EUDAMED1.5mm Cortex Screws 5mm, SS 316L EUDAMED
- Model / Reference
- 1.5mm Cortex Screws 7mm EUDAMEDT001.07 EUDAMED1.5mm Cortex Screws 14mm EUDAMEDT001.14 EUDAMED1.5mm Cortex Screws 15mm EUDAMEDT001.15 EUDAMED1.5mm Cortex Screws 10mm EUDAMEDT001.10 EUDAMED1.5mm Cortex Screws 8mm EUDAMEDT001.08 EUDAMED1.5mm Cortex Screws 12mm EUDAMEDT001.12 EUDAMED1.5mm Cortex Screws 6mm EUDAMEDT001.06 EUDAMED1.5mm Cortex Screws 5mm EUDAMEDT001.05 EUDAMED
Identifiers
- Primary DI / UDI-DI
- G648T001070 EUDAMEDG648T001140 EUDAMEDG648T001150 EUDAMEDG648T001100 EUDAMEDG648T001080 EUDAMEDG648T001120 EUDAMEDG648T001060 EUDAMEDG648T001050 EUDAMED
- Basic UDI-DI
- B-G648T001070 EUDAMEDB-G648T001140 EUDAMEDB-G648T001150 EUDAMEDB-G648T001100 EUDAMEDB-G648T001080 EUDAMEDB-G648T001120 EUDAMEDB-G648T001060 EUDAMEDB-G648T001050 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-G648T001070 | 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 (8)
- EUDAMED b1b51b01-c8cc-4733-9089-8cbec775d3de 61 fields · synced Aug 3, 2026
- EUDAMED 63ce1b61-8e6a-4a64-8710-44d2531f6069 61 fields · synced May 16, 2026
- EUDAMED d25f7592-514a-467f-b17d-91f39c78ca81 61 fields · synced May 16, 2026
- EUDAMED 5d76ac4e-418e-4f75-99b6-adfd51a19ad7 61 fields · synced May 17, 2026
- EUDAMED 27a3e152-cf15-4276-8f6b-2f5ecb38dc82 61 fields · synced May 18, 2026
- EUDAMED e63e86ae-97f6-4012-8aa8-5d92f6b12962 61 fields · synced May 18, 2026
- EUDAMED 5e749f4d-a282-41c5-bcd4-8eef9bbd99c6 61 fields · synced May 18, 2026
- EUDAMED a996de38-a154-4a4b-b7b8-de8981e084be 61 fields · synced May 19, 2026