Identity
- Trade Name
- T-LOC™ Triple Tray® Anterior - Box of 28 EUDAMED
- Device Name
- T-LOC Triple Tray EUDAMED
- Model / Reference
- 1006214CS EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00348783012095 EUDAMED
- Basic UDI-DI
- 00348783T-LOCTripleTrayN6 EUDAMED
- EMDN Code
- Q010503 IMPRESSION MATERIAL TRAYS, SINGLE-USE EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Germany EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
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
Category: Dental impression tray, single-use
T-LOC™ Triple Tray® Anterior - Box of 28 by Premier Dental Products Company — Class I — MDR — listed in EUDAMED — regulatory data on deviCERTS
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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 | 00348783T-LOCTripleTrayN6 | Class I | Active |
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Manufacturer
- Manufacturer
- Premier Dental Products Company
- EUDAMED SRN
- US-MF-000015778
- Authorised Representative
- MDSS GmbH DE-AR-000005430
Sources (1)
- EUDAMED a95b7397-627a-4b9b-9557-3905c5fbd0ac 61 fields · synced Oct 6, 2026