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PBG Cementless Hip Stem, Ti coating
EUDAMEDClass III (EU MDR)
Ref 130200007SRef 130150002SRef 130210008S
Identity
- Device Name
- PBG Cementless Hip Stem, Ti coating EUDAMED
- Model / Reference
- 130200007S EUDAMED130150002S EUDAMED130210008S EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06902139302113 EUDAMED06902139302069 EUDAMED06902139302120 EUDAMED
- Basic UDI-DI
- B-06902139302113 EUDAMEDB-06902139302069 EUDAMEDB-06902139302120 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
PBG Cementless Hip Stem, Ti 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-06902139302113 | 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 (3)
- EUDAMED 77dfa7cc-9e4d-49a4-bd1f-e8b4e3773d88 61 fields · synced Sep 18, 2026
- EUDAMED 5331d3ed-1d77-4fe8-83db-f3f47a1f18c3 61 fields · synced May 18, 2026
- EUDAMED 9426f435-daf0-4ce8-ae47-02adad49f03e 61 fields · synced May 18, 2026