Identity
- Trade Name
- ORT.008 EUDAMED
- Device Name
- Custom Procedure Trays EUDAMED
- Model / Reference
- 101913AN EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08710685082230 EUDAMED
- Basic UDI-DI
- 8710685TF07001003S3 EUDAMED
- EMDN Code
- V0599 CLINICAL PROCEDURES KITS NOT INCLUDED IN OTHER CLASSES - OTHER EUDAMED
Classification
- Device Class
- Class IIb EUDAMED
- Medical Purpose
- No EUDAMED
Clinical & Handling
Sterile
Yes
EUDAMED
Category: Ophthalmic surgical procedure kit, non-medicated, single-use
Ort.008 by Medica Europe B.V. — Class IIb — 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 | 8710685TF07001003S3 | Class IIb | Active |
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Manufacturer
- Manufacturer
- Medica Europe B.V.
- EUDAMED SRN
- NL-PR-000000117
Sources (1)
- EUDAMED ed90fb1f-d51d-44e9-83c9-a3698076b1b8 61 fields · synced Oct 6, 2026