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Montana Black 23
EUDAMEDClass I (EU MDR)
Ref R098MBModel Curettes and Scalers
by PDT, Inc.
Identity
- Trade Name
- Montana Black 23 EUDAMED
- Device Name
- Hygiene instruments EUDAMED
- Model / Reference
- Curettes and Scalers EUDAMEDR098MB EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00813677025388 EUDAMED
- Basic UDI-DI
- 0813677021801WC EUDAMED
- Direct Marketing DI
- 00813677025388 EUDAMED
- EMDN Code
- Q010399 SURGICAL DENTAL DEVICES - OTHER EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Netherlands 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
Montana Black 23 by PDT, Inc. — Class I — 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 | 0813677021801WC | Class I | Active |
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Manufacturer
- Manufacturer
- PDT, Inc.
- EUDAMED SRN
- US-MF-000045324
- Authorised Representative
- Emergo Europe B.V. NL-AR-000000116
Sources (1)
- EUDAMED a9436e1d-c0a3-432d-83a0-156a997df2eb 61 fields · synced Jul 21, 2026