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Boge Precision Duo
EUDAMEDClass I (EU MDR)
Ref R117Model Curettes and Scalers
by PDT, Inc.
Identity
- Trade Name
- Boge Precision Duo EUDAMED
- Device Name
- Hygiene instruments EUDAMED
- Model / Reference
- Curettes and Scalers EUDAMEDR117 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00813677025395 EUDAMED
- Basic UDI-DI
- 0813677021801WC EUDAMED
- Direct Marketing DI
- 00813677025395 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
Boge Precision Duo 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 f9e36144-20e2-4db3-9c12-26ff7fbb52e0 61 fields · synced Jul 8, 2026