Identity
- Trade Name
- BISS Profi Tray EUDAMED
- Model / Reference
- BISS Trays EUDAMEDBISS_ST-T2 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04260468254476 EUDAMED
- Basic UDI-DI
- 426046825TD03PG11CJ EUDAMED
- Direct Marketing DI
- 04260468254476 EUDAMED
- EMDN Code
- Q010399 SURGICAL DENTAL DEVICES - OTHER EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Germany 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
BISS Profi Tray by SDS Swiss Dental Solutions AG — 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 | 426046825TD03PG11CJ | Class I | Active |
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Manufacturer
- Manufacturer
- SDS Swiss Dental Solutions AG
- EUDAMED SRN
- CH-MF-000019073
- Authorised Representative
- SDS Deutschland GmbH DE-AR-000005774
Sources (1)
- EUDAMED 5bc349b0-3e0b-42df-ad62-6d31166f829d 61 fields · synced Jul 9, 2026