Identity
- Device Name
- Sigma SP EUDAMED
- Model / Reference
- MWSP EUDAMED
Identifiers
- Primary DI / UDI-DI
- 05060259071140 EUDAMED
- Basic UDI-DI
- B-05060259071140 EUDAMED
- EMDN Code
- A1102 SAMPLE COLLECTION SWABS WITH TRANSPORT MEDIUM EUDAMED
Classification
- Device Class
- Class IVD General EUDAMED
- Market of Registration
- Germany EUDAMED
Clinical & Handling
Sterile
Yes
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Microbial Substances
No
EUDAMED
Reagent
No
EUDAMED
Self Testing
No
EUDAMED
Near-Patient Testing
No
EUDAMED
Professional Testing
Yes
EUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
No
EUDAMED
Sigma SP by Medical Wire & Equipment Co Bath (Ltd) — Class IVD General — IVDD — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/IVDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/IVDD | B-05060259071140 | Class IVD General | Active |
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Manufacturer
- Manufacturer
- Medical Wire & Equipment Co Bath (Ltd)
- EUDAMED SRN
- GB-MF-000006736
- Authorised Representative
- Advena Limited MT-AR-000000234
Sources (1)
- EUDAMED b2493388-a9b0-4980-90f4-dea78c2bf2d6 61 fields · synced Jun 18, 2026