Identity
- Trade Name
- Burnisher EUDAMED
- Device Name
- Burnisher EUDAMED
- Model / Reference
- BURNISHER EUDAMEDCT-BB216 EUDAMED
Identifiers
- Primary DI / UDI-DI
- +G399CTBB2160L EUDAMED
- Basic UDI-DI
- ++G399BURNISHERYJ EUDAMED
- Direct Marketing DI
- +G399CTBB2160L 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
Burnisher by Crosstex (private) Limited. — 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 | ++G399BURNISHERYJ | Class I | Active |
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Manufacturer
- Manufacturer
- Crosstex (private) Limited.
- EUDAMED SRN
- PK-MF-000032784
- Authorised Representative
- ANTEX MEDI SOLUTION DE-AR-000008078
Sources (1)
- EUDAMED 1e450229-cd5b-406a-8faf-844548b677c4 61 fields · synced Jun 18, 2026