Identity
- Trade Name
- TruBrite EUDAMEDTruBrite Adhesive Retractor Light FDA UDI
- Generic Name
- Miniature adhesive light FDA UDI
- Device Name
- TruBrite EUDAMEDAdhesive Retractor Light FDA UDI
- Model / Reference
- ARL-1010 EUDAMEDFDA UDI
- Description
- Adhesive Retractor Light FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00811331011647 EUDAMED00811331011654 FDA UDI
- Basic UDI-DI
- 081133101ARL-1010KS EUDAMED
- FDA Product Code
- KYT FDA UDI
- EMDN Code
- Z129004 LIGHT SOURCES EUDAMED
- GMDN Term
- Miniature adhesive light FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 880.6350 FDA UDI
- Market of Registration
- Spain 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
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Prescription Use
No
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
TruBrite by Tz Medical, Inc. — Class I — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 081133101ARL-1010KS | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- TZ Medical inc
- EUDAMED SRN
- US-MF-000027311
- Authorised Representative
- CEpartner4U NL-AR-000000111
Sources (2)
- EUDAMED d0661d04-2106-47e7-8768-ef6230b2c32c 61 fields · synced Oct 6, 2026
- FDA UDI bb4d5301-0768-4ee6-95b5-74b6506d1b96 33 fields · synced May 30, 2026