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Labtec Pro
EUDAMEDClass IIa (EU MDR)
Ref Labtec Pro Economy KitModel Labtec ProRef Labtec Pro Super Economy Kit
Identity
- Trade Name
- Labtec Pro EUDAMED
- Device Name
- Labtec Pro EUDAMED
- Model / Reference
- Labtec Pro EUDAMEDLabtec Pro Economy Kit EUDAMEDLabtec Pro Super Economy Kit EUDAMED
Identifiers
- Primary DI / UDI-DI
- D810PLTPNATEK11 EUDAMEDD810PLTPNATSEK11 EUDAMED
- Basic UDI-DI
- ++D810LabtecPro26 EUDAMED
- EMDN Code
- Q010699 MATERIALS FOR THE PREPARATION OF CUSTOM-MADE DENTAL DEVICES - OTHER EUDAMED
Classification
- Device Class
- Class IIa 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
Labtec Pro by Astron Dental — Class IIa — MDR — listed in EUDAMED — regulatory data on deviCERTS
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 | ++D810LabtecPro26 | Class IIa | Active |
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Manufacturer
- Manufacturer
- Astron Dental
- EUDAMED SRN
- US-MF-000034006
- Authorised Representative
- Kentzler-Kaschner Dental GmbH DE-AR-000006367
Sources (2)
- EUDAMED beb2c90c-789b-422c-b34d-6f9014f1a159 61 fields · synced Jul 12, 2026
- EUDAMED e6015ef8-a02a-4242-ae76-45524562b38e 61 fields · synced May 19, 2026