Identity
- Device Name
- swab EUDAMED
- Model / Reference
- KHSW-TH/KHSW-MT/KHSW-NSⅠ/KHSW-NSⅡ EUDAMEDMDR EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06974816380004 EUDAMED06974816380028 EUDAMED06974816380035 EUDAMED
- Basic UDI-DI
- 697481638KH001JM EUDAMED
- EMDN Code
- A1101 SAMPLE COLLECTION NEUTRAL SWABS EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Austria 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
swab by Koch Biotechnology (Beijing) Co., 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 | 697481638KH001JM | Class I | Active |
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Manufacturer
- Manufacturer
- Koch Biotechnology (Beijing) Co., Ltd.
- EUDAMED SRN
- CN-MF-000024548
- Authorised Representative
- RIOMAVIX SOCIEDAD LIMITADA ES-AR-000001202
Sources (3)
- EUDAMED 0ed393ae-8ac0-4079-af09-cd2f14b520f9 61 fields · synced Jul 23, 2026
- EUDAMED c68b40aa-ac59-4d87-bef0-65b8b5a9b5ed 61 fields · synced May 16, 2026
- EUDAMED 90317ccc-fec6-4c8f-b2b0-a46804202d35 61 fields · synced May 19, 2026