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Probact Medical Swab - custom label
EUDAMEDClass IVD General (EU MDR)
Ref TS/5-1:7115Model Probact Medical Swab - customised label
Identity
- Trade Name
- Probact Medical Swab - custom label EUDAMED
- Device Name
- Probact: Amies w/o charcoal; birch wood shaft/cotton tip swab - customised label EUDAMED
- Model / Reference
- Probact Medical Swab - customised label EUDAMEDTS/5-1:7115 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 05060488973789 EUDAMED
- Basic UDI-DI
- B-05060488973789 EUDAMED
- EMDN Code
- A1102 SAMPLE COLLECTION SWABS WITH TRANSPORT MEDIUM EUDAMED
Classification
- Device Class
- Class IVD General EUDAMED
- Market of Registration
- Malta 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
Category: General-purpose absorbent tip applicator/swab, single-use
Probact Medical Swab - custom label by Technical Service Consultants Ltd — Class IVD General — IVDD — listed in EUDAMED — regulatory data on deviCERTS
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Also classified as General-purpose absorbent tip applicator/swab, single-use.
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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-05060488973789 | Class IVD General | Active |
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Manufacturer
- Manufacturer
- Technical Service Consultants Ltd
- EUDAMED SRN
- GB-MF-000012821
- Authorised Representative
- Advena Limited MT-AR-000000234
Sources (1)
- EUDAMED ff75186f-125b-4f5d-affd-28ac2f037861 61 fields · synced Jul 28, 2026