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Reddroplab SmartCo
EUDAMEDClass IIa (EU MDR)
Ref RDL01_STIModel RDL01
by Red drop Lab
Identity
- Device Name
- Reddroplab SmartCo EUDAMED
- Model / Reference
- RDL01 EUDAMEDRDL01_STI EUDAMED
Identifiers
- Primary DI / UDI-DI
- 07649988456176 EUDAMED
- Basic UDI-DI
- 76499884561RDL01RE EUDAMED
- EMDN Code
- A1102 SAMPLE COLLECTION SWABS WITH TRANSPORT MEDIUM EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Medical Purpose
- Procedure pack for home collection of a vaginal swab. EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Category: General-purpose absorbent tip applicator/swab, single-use
Reddroplab SmartCo by Red drop Lab — Class IIa — 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 | 76499884561RDL01RE | Class IIa | Active |
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Manufacturer
- Manufacturer
- Red drop Lab
- EUDAMED SRN
- CH-PR-000047258
Sources (1)
- EUDAMED 20d677cd-c3b8-44de-9a89-60263194adaa 61 fields · synced Jun 18, 2026