Identity
- Trade Name
- Throat Swab EUDAMED
- Device Name
- Throat Swab EUDAMED
- Model / Reference
- O-SFK70-K EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08683391760191 EUDAMED
- Basic UDI-DI
- 868339176OSFK70K5A EUDAMED
- EMDN Code
- A1101 SAMPLE COLLECTION NEUTRAL SWABS EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Türkiye EUDAMED
Clinical & Handling
Sterile
Yes
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
Throat Swab by İnnomed Laboratuvar İth. İhr. San. Tic. Ltd. Şti. — 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 | 868339176OSFK70K5A | Class IIa | Active |
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Manufacturer
- Manufacturer
- İnnomed Laboratuvar İth. İhr. San. Tic. Ltd. Şti.
- EUDAMED SRN
- TR-MF-000021101
Sources (1)
- EUDAMED 3b33f078-ecd6-4219-8e56-f311766f2ec6 61 fields · synced Jun 18, 2026