Identity
- Trade Name
- Initial Pack Siltrax EUDAMED
- Device Name
- Siltrax Plain EUDAMED
- Model / Reference
- 07000 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00310866002569 EUDAMED
- Basic UDI-DI
- 03108662001FW EUDAMED
- EMDN Code
- Q010204 RETRACTION WIRES AND GINGIVAL RETRACTORS EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Sweden 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
Category: Gingival retraction cord, non-medicated
Initial Pack Siltrax by Pascal Company, Inc. — Class I — MDR — listed in EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as Gingival retraction cord, non-medicated.
- Smartcord 2 — EASTDENT Co., Ltd · Class I
- roeko Retracto / braided / non-impregnated, x-fine (0), 225 cm — Coltène/Whaledent GmbH + Co. KG · Class I
- 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
- Mouth Prop — Huanghua Promisee Dental Co.Ltd. · 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 | 03108662001FW | Class I | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Pascal Company Inc.
- EUDAMED SRN
- US-MF-000032036
- Authorised Representative
- Emergo Europe B.V. NL-AR-000000116
Sources (1)
- EUDAMED 1a594934-1b14-479d-8ccd-997aae8fb37b 61 fields · synced Jul 16, 2026