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Disposable sampling swab
EUDAMEDClass I (EU MDR)
Ref ZCY-04Model B;C;C-01;C-010;C-02;C-03;C-030;C-031;C-032;C-04;C-040;C-041;C-042;C-05;C-050;C-051;C-052;ZCY-03; ZCY-04
Identity
- Device Name
- Disposable sampling swab EUDAMED
- Model / Reference
- B;C;C-01;C-010;C-02;C-03;C-030;C-031;C-032;C-04;C-040;C-041;C-042;C-05;C-050;C-051;C-052;ZCY-03; ZCY-04 EUDAMEDZCY-04 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06973697819221 EUDAMED
- Basic UDI-DI
- 697369781052R9 EUDAMED
- EMDN Code
- A1101 SAMPLE COLLECTION NEUTRAL SWABS EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Germany 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
Disposable sampling swab by Jiangsu HanHeng Medical Technology 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 | 697369781052R9 | Class I | Active |
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Manufacturer
- Manufacturer
- Jiangsu HanHeng Medical Technology Co., Ltd.
- EUDAMED SRN
- CN-MF-000018784
- Authorised Representative
- Luxus Lebenswelt GmbH DE-AR-000005110
Sources (1)
- EUDAMED 6605b1c4-f23d-4a51-8905-b5eb2dee590b 61 fields · synced Jun 18, 2026