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TBG Cementless Hip Stem, HA coating
EUDAMEDClass III (EU MDR)
Ref 130560002SRef 130600006SRef 130610007SRef 130590005SRef 130620008S
Identity
- Device Name
- TBG Cementless Hip Stem, HA coating EUDAMED
- Model / Reference
- 130560002S EUDAMED130600006S EUDAMED130610007S EUDAMED130590005S EUDAMED130620008S EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06902139329547 EUDAMED06902139329585 EUDAMED06902139329592 EUDAMED06902139329578 EUDAMED06902139329608 EUDAMED
- Basic UDI-DI
- B-06902139329547 EUDAMEDB-06902139329585 EUDAMEDB-06902139329592 EUDAMEDB-06902139329578 EUDAMEDB-06902139329608 EUDAMED
- EMDN Code
- P090804010202 UNCEMENTED FEMORAL STEMS FOR PRIMARY IMPLANT, WITH FIXED NECK, ANATOMICAL EUDAMED
Classification
- Device Class
- Class III EUDAMED
- Market of Registration
- Croatia EUDAMED
Clinical & Handling
Sterile
Yes
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
TBG Cementless Hip Stem, HA coating by Double Medical Technology Inc. — Class III — 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-06902139329547 | Class III | Active |
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Manufacturer
- Manufacturer
- Double Medical Technology Inc.
- EUDAMED SRN
- CN-MF-000009048
- Authorised Representative
- Lotus NL B.V. NL-AR-000000121
Sources (5)
- EUDAMED 4c1edc9e-5cef-4bed-901c-8db6a00b92e1 61 fields · synced Jul 21, 2026
- EUDAMED 08d82797-4ce0-4cfe-88bd-d9d22ab3a0ca 61 fields · synced May 17, 2026
- EUDAMED 7c2c701a-34f4-4671-b643-c610df625a49 61 fields · synced May 17, 2026
- EUDAMED 6b71ee7f-0d07-4cc5-9d42-0d247ef920e0 61 fields · synced May 17, 2026
- EUDAMED 489f5cec-6648-400f-81b1-8a57922905cf 61 fields · synced May 17, 2026