← Back to catalogue
U-Swab™ Fecal
EUDAMEDClass IVD General (EU MDR)
Ref M200146Ref M200145Ref M200148
Identity
- Device Name
- U-SWAB™ FECAL EUDAMEDU-SWAB™ FECAL DRY– Scoop – 16x100 Vial – Dry EUDAMED
- Model / Reference
- M200146 EUDAMEDM200145 EUDAMEDM200148 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 05060259076343 EUDAMED05060259076398 EUDAMED05060259076336 EUDAMED
- Basic UDI-DI
- B-05060259076343 EUDAMEDB-05060259076398 EUDAMEDB-05060259076336 EUDAMED
- EMDN Code
- W05019001 FAECES COLLECTION DEVICES EUDAMED
Classification
- Device Class
- Class IVD General EUDAMED
- Market of Registration
- Austria EUDAMED
Clinical & Handling
Sterile
Yes
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Microbial Substances
No
EUDAMED
Reagent
No
EUDAMED
Self Testing
Yes
EUDAMED
Near-Patient Testing
No
EUDAMED
Professional Testing
No
EUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
No
EUDAMED
U-Swab™ Fecal 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-05060259076343 | Class IVD General | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Medical Wire & Equipment Co Bath (Ltd)
- EUDAMED SRN
- GB-MF-000006736
- Authorised Representative
- Advena Limited MT-AR-000000234
Sources (3)
- EUDAMED a6ec8e55-8474-45b5-ae86-286179d9f715 61 fields · synced Oct 6, 2026
- EUDAMED eed51d0c-14ea-4627-b12d-a47a17b65504 61 fields · synced May 18, 2026
- EUDAMED e3355cc0-e198-4ad3-9065-26c55744ac54 61 fields · synced May 18, 2026