Identity
- Trade Name
- Individo-Set EUDAMED
- Device Name
- Individo-Set - IIa EUDAMED
- Model / Reference
- 1001 5050 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04260530126953 EUDAMED
- Basic UDI-DI
- 4260253261001RE EUDAMED
- EMDN Code
- V0599 CLINICAL PROCEDURES KITS NOT INCLUDED IN OTHER CLASSES - OTHER EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Medical Purpose
- zur Unterstützung einer medizinischen Behandlung EUDAMED
Clinical & Handling
Sterile
Yes
EUDAMED
Category: Ophthalmic surgical procedure kit, non-medicated, single-use
Individo-Set by Imtegra GmbH & Co KG — Class IIa — MDR — listed in EUDAMED — regulatory data on deviCERTS
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Also classified as Ophthalmic surgical procedure kit, non-medicated, single-use.
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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 | 4260253261001RE | Class IIa | Active |
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Manufacturer
- Manufacturer
- Imtegra GmbH & Co KG
- EUDAMED SRN
- DE-PR-000006448
Sources (1)
- EUDAMED 74766ae5-f7bf-4af4-93aa-5eb19936544a 61 fields · synced Oct 6, 2026