Identity
- Trade Name
- SK-4S: 2 x regular swabs EUDAMED
- Device Name
- Isohelix Swab Pack, non sterile EUDAMED
- Model / Reference
- SK-4S EUDAMED
Identifiers
- Primary DI / UDI-DI
- 05060544101132 EUDAMED
- Basic UDI-DI
- 506054410SwabPack3W EUDAMED
- Direct Marketing DI
- 05060544101132 EUDAMED
- EMDN Code
- A1101 SAMPLE COLLECTION NEUTRAL SWABS EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Italy EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
Reprocessed
No
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Category: General-purpose absorbent tip applicator/swab, single-use
SK-4S: 2 x regular swabs by Cell Projects Ltd — Class I — MDR — 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/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 506054410SwabPack3W | Class I | Active |
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Manufacturer
- Manufacturer
- Cell Projects Ltd
- EUDAMED SRN
- GB-MF-000002266
- Authorised Representative
- Advena Limited MT-AR-000000234
Sources (1)
- EUDAMED ae0fd980-d72f-43ba-87c1-d6fb10b5cf49 61 fields · synced Jul 20, 2026