Identity
- Trade Name
- I-MC-SP-30D EUDAMED
- Device Name
- Reusable Instruments EUDAMED
- Model / Reference
- CAT-8070 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06009544052012 EUDAMED
- Basic UDI-DI
- 6009544038769E EUDAMED
- Direct Marketing DI
- 06009544052012 EUDAMED
- EMDN Code
- L99 SURGICAL INSTRUMENTS, REUSABLE - OTHER EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Portugal 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
I-Mc-Sp-30d 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 | 6009544038769E | 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 76ae3535-0c5c-439e-aaf2-eaa7298c17b0 61 fields · synced Jul 12, 2026