Identity
- Trade Name
- Retrax AS Solution 15mL EUDAMED
- Device Name
- Retrax AS Solution EUDAMED
- Model / Reference
- 16600 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00310866001685 EUDAMED
- Basic UDI-DI
- 03108665002GM EUDAMED
- EMDN Code
- Q010204 RETRACTION WIRES AND GINGIVAL RETRACTORS EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Italy 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
Retrax AS Solution 15mL by Pascal Company, Inc. — 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 | 03108665002GM | Class I | Active |
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Manufacturer
- Manufacturer
- Pascal Company Inc.
- EUDAMED SRN
- US-MF-000032036
- Authorised Representative
- Emergo Europe B.V. NL-AR-000000116
Sources (1)
- EUDAMED 81b09bb8-ff8a-4899-9cd2-ee6fa4e2db48 61 fields · synced Jul 25, 2026