Identity
- Trade Name
- Transpose Ultra EUDAMED
- Device Name
- Transpose Ultra EUDAMED
- Model / Reference
- 11188-01 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00852059007116 EUDAMED
- Basic UDI-DI
- B-00852059007116 EUDAMED
- EMDN Code
- V901699 SPECIALIST SURGICAL INSTRUMENTS AND KITS NOT INCLUDED IN OTHER CLASSES, SINGLE-USE - OTHER EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Germany EUDAMED
Clinical & Handling
Sterile
Yes
EUDAMED
Implantable
No
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
Category: General internal orthopaedic fixation system implantation kit
Transpose Ultra by InGeneron Inc. — Class I — MDD — listed in EUDAMED — regulatory data on deviCERTS
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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-00852059007116 | Class I | Active |
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Manufacturer
- Manufacturer
- InGeneron Inc.
- EUDAMED SRN
- US-MF-000040203
- Authorised Representative
- CEpartner4U NL-AR-000000111
Sources (1)
- EUDAMED e5b5609f-f322-47a1-bcd9-80e127077ab3 61 fields · synced Jun 18, 2026