Identity
- Trade Name
- File EUDAMED
- Device Name
- File EUDAMED
- Model / Reference
- FILES EUDAMEDCT-FH3/73 EUDAMED
Identifiers
- Primary DI / UDI-DI
- +G399CTFH3730Z EUDAMED
- Basic UDI-DI
- ++G399FILEG2 EUDAMED
- Direct Marketing DI
- +G399CTFH3730Z EUDAMED
- EMDN Code
- L159019 DENTAL FINISHING RASPS AND FILES, REUSABLE 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
File by Crosstex (private) Limited. — 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 | ++G399FILEG2 | 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 11754da9-0486-4753-9801-48ce2e0d32cb 61 fields · synced Aug 4, 2026