Identity
- Trade Name
- Spreader EUDAMED
- Device Name
- Spreader EUDAMED
- Model / Reference
- SPREADERS EUDAMEDCT-RCSW1S EUDAMED
Identifiers
- Primary DI / UDI-DI
- +G399CTRCSW1S30Z EUDAMED
- Basic UDI-DI
- ++G399SPREADERSYW EUDAMED
- Direct Marketing DI
- +G399CTRCSW1S30Z EUDAMED
- EMDN Code
- L159012 ENDODONTIC SPREADERS AND PLUGGERS, 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
Spreader 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 | ++G399SPREADERSYW | 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 f80e7498-9352-4243-ac30-ab656e4fd108 61 fields · synced Sep 17, 2026