Disposable sampling swab
EUDAMEDFDA UDIClass I (EU MDR)
Identity
- Trade Name
- HanHeng FDA UDI
- Generic Name
- General-purpose absorbent tip applicator/swab, single-use FDA UDI
- 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-03 EUDAMEDG-series EUDAMEDG-0136 EUDAMEDG-0135 EUDAMEDD;D-01;D-02;D-03;E;E-01;E-02;E-03;E-000;E-010;E-020;E-030;F;F-01;F-02;F-03;F-000;F-010;F-020;F-030 EUDAMEDE-010 EUDAMEDFDA UDIG-0137 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06973697819207 EUDAMED06973697818187 EUDAMED06973697818170 EUDAMED06973697810785 EUDAMEDFDA UDI06973697818194 EUDAMED
- Basic UDI-DI
- 697369781052R9 EUDAMED697369781089RY EUDAMED697369781069RS EUDAMED
- FDA Product Code
- KXG FDA UDI
- EMDN Code
- A1101 SAMPLE COLLECTION NEUTRAL SWABS EUDAMED
- GMDN Term
- General-purpose absorbent tip applicator/swab, single-use FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 880.6025 FDA UDI
- Market of Registration
- Germany EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
Single Use
Yes
Implantable
No
Reusable
No
Contains Latex
No
Reprocessed
No
CMR Substance
No
Human-derived
No
Human Tissues
No
Animal Tissues
No
Endocrine Disruptor
No
Administering Medicine
No
Measuring Function
No
Incorporates Medicinal Product
No
Prescription Use
No
Over-the-Counter
No
Convenience Kit
No
Combination Product
No
HCT/P
No
Premarket Exempt
Yes
Lot / Batch Number
Yes
Serial Number
No
Expiration Date
Yes
Manufacturing Date
Yes
Category: General-purpose absorbent tip applicator/swab, single-use
Disposable sampling swab by Jiangsu HanHeng Medical Technology Co., Ltd. — Class I — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as General-purpose absorbent tip applicator/swab, single-use.
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- CITOTEST — CITOTEST LABWARE MANUFACTURING CO.,LTD · Class I
Authorization Coverage (2 countries)
Regulatory Authorizations
CE/MDR
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 697369781052R9 | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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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 (6)
- EUDAMED 4681a2ce-00da-4cfb-b914-0e2adef66863 61 fields · synced Jul 23, 2026
- EUDAMED 04c0241e-9d0a-4fb5-b112-759d88401070 61 fields · synced May 17, 2026
- EUDAMED 1a18741a-98fa-4270-9d7f-93ea865af2a9 61 fields · synced May 17, 2026
- EUDAMED 948599ef-7b0b-43ca-81e3-857a8a70c9c1 61 fields · synced May 18, 2026
- EUDAMED cfa1881f-ef7c-4450-a8b9-0a6eea8774bc 61 fields · synced May 18, 2026
- FDA UDI b1516771-ea1d-43ad-87a0-68cf7d701f5c 32 fields · synced May 29, 2026