Identity
- Trade Name
- Individo-Set EUDAMED
- Device Name
- Individo-Set - I EUDAMED
- Model / Reference
- 1015 4013 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04260679315355 EUDAMED
- Basic UDI-DI
- 4260253261014RP EUDAMED
- EMDN Code
- V0599 CLINICAL PROCEDURES KITS NOT INCLUDED IN OTHER CLASSES - OTHER EUDAMED
Classification
- Device Class
- Class I 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 I — 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 | 4260253261014RP | Class I | Active |
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Manufacturer
- Manufacturer
- Imtegra GmbH & Co KG
- EUDAMED SRN
- DE-PR-000006448
Sources (1)
- EUDAMED 2c148341-8683-4693-a4da-ed35034f141d 61 fields · synced Jun 18, 2026