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Prokarimi Microbiota Sample Collection Kit
EUDAMEDClass A (EU MDR)
Ref 1030Model Prokarimi Microbiota Sample Collection Kit
Identity
- Trade Name
- Prokarimi Microbiota Sample Collection Kit EUDAMED
- Device Name
- Prokarimi Microbiota Sample Collection Kit EUDAMED
- Model / Reference
- Prokarimi Microbiota Sample Collection Kit EUDAMED1030 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 07090064750037 EUDAMED
- Basic UDI-DI
- 7090064752710YK EUDAMED
- EMDN Code
- A1102 SAMPLE COLLECTION SWABS WITH TRANSPORT MEDIUM EUDAMED
Classification
- Device Class
- Class A EUDAMED
- Market of Registration
- Norway EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Microbial Substances
No
EUDAMED
Reagent
Yes
EUDAMED
Self Testing
No
EUDAMED
Near-Patient Testing
No
EUDAMED
Professional Testing
No
EUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
No
EUDAMED
New Device
Yes
EUDAMED
Category: General-purpose absorbent tip applicator/swab, single-use
Prokarimi Microbiota Sample Collection Kit by Genetic Analysis AS — Class A — IVDR — 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/IVDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/IVDR | 7090064752710YK | Class A | Active |
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Manufacturer
- Manufacturer
- Genetic Analysis AS
- EUDAMED SRN
- NO-MF-000023768
Sources (1)
- EUDAMED 22a176c7-72f9-4a8e-844f-416e58be5e4f 61 fields · synced Jul 12, 2026