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In'Tech Medical 30mm Surgical Illuminator
FDA UDIEUDAMEDClass I (US FDA UDI)
Ref S06 ITM 232Model 30mm Surgical Illuminator
Identity
- Trade Name
- In'Tech Medical 30mm Surgical Illuminator FDA UDI
- Generic Name
- Surgical instrument fibreoptic light FDA UDI
- Model / Reference
- 30mm Surgical Illuminator EUDAMEDS06 ITM 232 EUDAMED009568 FDA UDI
Identifiers
- Catalog Number
- S06 ITM 232 FDA UDI
- Primary DI / UDI-DI
- 00812432021597 EUDAMEDFDA UDI
- Basic UDI-DI
- B-00812432021597 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
- France EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
EUDAMEDFDA UDI
Single Use
Yes
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
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
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Surgical instrument fibreoptic light
In'Tech Medical 30mm Surgical Illuminator by Lumitex, Inc. — Class I — MDD, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
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Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Unknown
MDD
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDD | — | Class I | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Lumitex, Inc.
Sources (2)
- FDA UDI 55474ce4-3775-4d80-8a36-668bd11faf19 33 fields · synced Jun 19, 2026
- EUDAMED dd5834b9-87f0-40de-b7f7-aed9c208ad97 61 fields · synced Jun 14, 2026