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Retraction wires & gingival retractors
EUDAMEDClass I (EU MDR)
Ref Q010204
by Clinimed
Identity
- Trade Name
- Retraction wires & gingival retractors EUDAMED
- Device Name
- Retraction wires & gingival retractors EUDAMED
- Model / Reference
- Q010204 EUDAMED
Identifiers
- Primary DI / UDI-DI
- M294Q0102040 EUDAMED
- Basic UDI-DI
- ++M294Q010204EL EUDAMED
- EMDN Code
- Q010204 RETRACTION WIRES AND GINGIVAL RETRACTORS 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: Gingival retraction cord, non-medicated
Retraction wires & gingival retractors by Clinimed — Class I — MDR — listed in EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as Gingival retraction cord, non-medicated.
- R-101 — PASCAL COMPANY, INC. · Class I
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- Hilo de retracción tejido Nº2 Dentaflux — J RIPOLL SL · Class I
- Hilo de retracción tejido Nº00 Dentaflux — J RIPOLL SL · Class I
- Henry Schein — HENRY SCHEIN, INC. · U
- roeko Stay-put / non-impregnated, x-fine (0), 183 cm — Coltène/Whaledent GmbH + Co. KG · Class I
- G-DENT Retraction Cord N.000 — UAB "Medicinos linija" · Class I
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 | ++M294Q010204EL | Class I | Active |
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Manufacturer
- Manufacturer
- Clinimed
- EUDAMED SRN
- US-MF-000033329
- Authorised Representative
- ANTEX MEDI SOLUTION DE-AR-000008078
Sources (1)
- EUDAMED e1fe3eaf-ef22-4461-9aec-945b3bcc8b67 61 fields · synced Jul 8, 2026