Surgical Illuminator - 4mm Max Cable Diameter
EUDAMEDFDA UDIClass IIa (EU MDR)
Identity
- Trade Name
- Pioneer Surgical Surgical Illuminator FDA UDI
- Generic Name
- Surgical instrument fibreoptic light FDA UDI
- Device Name
- Surgical Illuminator - 4mm Max Cable Diameter EUDAMED
- Model / Reference
- LightMat Surgical Illuminator Product Family EUDAMED38-LIGHT-4 EUDAMED008383 FDA UDI
Identifiers
- Catalog Number
- 38-LIGHT-1 FDA UDI
- Primary DI / UDI-DI
- 00812432021313 EUDAMEDFDA UDI
- Basic UDI-DI
- B-00812432021313 EUDAMED
- FDA Product Code
- FDG FDA UDI
- EMDN Code
- V9012 NON-SPECIALIST SURGICAL INSTRUMENTS AND KITS, SINGLE-USE EUDAMED
- GMDN Term
- Surgical instrument fibreoptic light FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass I FDA UDI
- Regulation Number
- 876.4530 FDA UDI
- Market of Registration
- Austria EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
Single Use
Yes
Implantable
No
Reusable
No
Contains Latex
No
Reprocessed
No
Human-derived
No
Human Tissues
No
Animal Tissues
No
Administering Medicine
No
Measuring Function
No
Incorporates Medicinal Product
No
Prescription Use
Yes
Over-the-Counter
No
Convenience Kit
No
Combination Product
No
HCT/P
No
Premarket Exempt
Yes
Lot / Batch Number
Yes
Serial Number
No
Expiration Date
Yes
Manufacturing Date
No
Category: Surgical retractor/retraction system blade, single-use
Surgical Illuminator - 4mm Max Cable Diameter by Lumitex Medical Devices, Inc. — Class IIa — MDD, FDA UDI — listed in EUDAMED, FDA GUDID
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Also classified as Surgical retractor/retraction system blade, single-use.
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Authorization Coverage (2 countries)
Regulatory Authorizations
CE/MDD
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | B-00812432021313 | Class IIa | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIa | Pending data |
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Manufacturer
- Manufacturer
- Lumitex Medical Devices, Inc.
- EUDAMED SRN
- US-MF-000030520
- Authorised Representative
- MDSS GmbH DE-AR-000005430
Sources (2)
- EUDAMED 3feb7d1b-d211-497c-afbf-3a61e0c6030a 61 fields · synced Jun 18, 2026
- FDA UDI 01ac59ec-8e65-41a1-aed2-b957019d5ff2 33 fields · synced May 30, 2026