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Pindex System 100 Pindex Replacement Blades - 0.010
EUDAMEDClass I (EU MDR)
Ref PX302
Identity
- Trade Name
- Pindex System 100 Pindex Replacement Blades - 0.010 EUDAMED
- Device Name
- Pindex Model and Die Fabrication System EUDAMED
- Model / Reference
- PX302 EUDAMED
Identifiers
- Primary DI / UDI-DI
- D661PX3021 EUDAMED
- Basic UDI-DI
- ++D661019KN EUDAMED
- EMDN Code
- Q01010199 DENTAL RESTORATION DEVICES - OTHER EUDAMED
Classification
- Device Class
- Class I 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
Category: Dental appliance fabrication material, ceramic
Pindex System 100 Pindex Replacement Blades - 0.010 by Coltene/Whaledent Inc. — 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 | ++D661019KN | Class I | 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 deda680b-fa29-4d04-a076-e8abb4ef4d08 61 fields · synced Aug 3, 2026