Identity
- Device Name
- Handle EUDAMED
- Model / Reference
- UNT-I-801250 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04260706010680 EUDAMED
- Basic UDI-DI
- 42607060101handlePL EUDAMED
- Direct Marketing DI
- 04260706010680 EUDAMED
- EMDN Code
- L098099 ORTHOPAEDIC AND TRAUMATOLOGICAL SURGERY INSTRUMENTS, REUSABLE - OTHER ACCESSORIES EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Germany EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
Reprocessed
No
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Handle by Unintech GmbH — Class I — MDR — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 42607060101handlePL | Class I | Active |
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Manufacturer
- Manufacturer
- Unintech GmbH
- EUDAMED SRN
- DE-MF-000005136
Sources (1)
- EUDAMED 0d43dd9a-12fe-424f-bdd9-57d08c1b0830 61 fields · synced Jun 19, 2026