Identity
- Model / Reference
- STERLINK mini EUDAMEDSTERLINK EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08800066500283 EUDAMED
- Basic UDI-DI
- B-08800066500283 EUDAMED
- EMDN Code
- S900199 DEVICES FOR GAS PLASMA STERILISATION (EXCLUDING CAT. D - Z) - OTHER EUDAMED
Classification
- Device Class
- Class IIb EUDAMED
- Market of Registration
- Germany EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
Reprocessed
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
STERLINK mini by Plasmapp Co., Ltd. — Class IIb — MDD — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | B-08800066500283 | Class IIb | Active |
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Manufacturer
- Manufacturer
- Plasmapp Co., Ltd
- EUDAMED SRN
- KR-MF-000012193
- Authorised Representative
- MedNet EC-REP GmbH DE-AR-000000002
Sources (1)
- EUDAMED 464cad91-2b90-44af-a139-0cc1b0ebafbf 61 fields · synced May 23, 2026