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ParaPost Starter Drill and Universal Hand Driver
EUDAMEDClass IIa (EU MDR)
Ref TEDC1
Identity
- Trade Name
- ParaPost Starter Drill and Universal Hand Driver EUDAMED
- Device Name
- ParaPost Drills EUDAMED
- Model / Reference
- TEDC1 EUDAMED
Identifiers
- Primary DI / UDI-DI
- D661TEDC11 EUDAMED
- Basic UDI-DI
- B-D661TEDC11 EUDAMED
- EMDN Code
- Q010199 CONSERVATIVE DENTISTRY AND ENDODONTICS DEVICES - OTHER EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Germany EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
Yes
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
ParaPost Starter Drill and Universal Hand Driver by Coltene/Whaledent Inc. — Class IIa — MDD — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | B-D661TEDC11 | Class IIa | Active |
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Manufacturer
- Manufacturer
- Coltene/Whaledent Inc.
- EUDAMED SRN
- US-MF-000015761
- Authorised Representative
- Coltène/Whaledent GmbH + Co. KG DE-AR-000005719
Sources (1)
- EUDAMED 1dee8a58-20bc-4550-8d3d-07c5e4ea1fb4 61 fields · synced Jun 17, 2026