Identity
- Device Name
- General Use Instruments EUDAMED
- Model / Reference
- I-GSF-6252-L6 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06009544050988 EUDAMED
- Basic UDI-DI
- 6009544039108M EUDAMED
- Direct Marketing DI
- 06009544050988 EUDAMED
- EMDN Code
- Q010599 DENTAL INSTRUMENTS, SINGLE-USE - OTHER EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Portugal 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
General Use Instruments by Southern Implants (pty) Ltd — 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 | 6009544039108M | Class I | Active |
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Manufacturer
- Manufacturer
- Southern Implants (Pty) Ltd
- EUDAMED SRN
- ZA-MF-000035362
- Authorised Representative
- Southern Implants Europe AB SE-AR-000032508
Sources (1)
- EUDAMED 90d12eff-8a31-43e2-b4b8-aacb25e8502d 61 fields · synced Jun 19, 2026