Identity
- Model / Reference
- Bifurcated Illuminator EUDAMED013420 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00812432023157 EUDAMED
- Basic UDI-DI
- B-00812432023157 EUDAMED
- EMDN Code
- V9012 NON-SPECIALIST SURGICAL INSTRUMENTS AND KITS, SINGLE-USE EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Spain 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: Surgical retractor/retraction system blade, single-use
013420 by Lumitex Medical Devices, Inc. — Class IIa — MDD — listed in EUDAMED — regulatory data on deviCERTS
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Also classified as Surgical retractor/retraction system blade, single-use.
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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-00812432023157 | Class IIa | Active |
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Manufacturer
- Manufacturer
- Lumitex Medical Devices, Inc.
- EUDAMED SRN
- US-MF-000030520
- Authorised Representative
- MDSS GmbH DE-AR-000005430
Sources (1)
- EUDAMED 49ed512d-eaf7-4a5f-9e4b-f7dbd7775d8f 61 fields · synced Jul 20, 2026