Identity
- Device Name
- Sigma GBS EUDAMED
- Model / Reference
- MWGBS EUDAMEDMWGBST EUDAMED
Identifiers
- Primary DI / UDI-DI
- 05060259075056 EUDAMED05060259075698 EUDAMED
- Basic UDI-DI
- B-05060259075056 EUDAMEDB-05060259075698 EUDAMED
- EMDN Code
- A1102 SAMPLE COLLECTION SWABS WITH TRANSPORT MEDIUM EUDAMED
Classification
- Device Class
- Class I EUDAMEDClass IVD General EUDAMED
- Market of Registration
- Germany EUDAMED
Clinical & Handling
Sterile
Yes
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
Microbial Substances
No
EUDAMED
Reagent
No
EUDAMED
Self Testing
No
EUDAMED
Near-Patient Testing
No
EUDAMED
Professional Testing
Yes
EUDAMED
Companion Diagnostics
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Surgical Instrument
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Category: General-purpose absorbent tip applicator/swab, single-use
Sigma GBS by Medical Wire & Equipment Co Bath (Ltd) — Class I — IVDD, MDD — listed in EUDAMED — regulatory data on deviCERTS
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Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/IVDD
European Union Active
CE/MDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/IVDD | B-05060259075056 | Class I | Active |
| EUDAMED | European Union | CE/MDD | B-05060259075056 | Class I | 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 (2)
- EUDAMED dafe6ccc-8bd6-41ee-b23c-e22d09604495 61 fields · synced Jul 9, 2026
- EUDAMED 824283a5-d00c-40de-8322-a70995cb0369 61 fields · synced May 18, 2026