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
- G-series EUDAMEDG-0116 EUDAMEDFDA UDI
Identifiers
- Primary DI / UDI-DI
- 06973697811188 EUDAMEDFDA UDI
- Basic UDI-DI
- 697369781089RY 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
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Also classified as General-purpose absorbent tip applicator/swab, single-use.
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Authorization Coverage (2 countries)
Regulatory Authorizations
CE/MDR
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 697369781089RY | 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 (2)
- EUDAMED c02d49cb-31a5-4ce7-80c2-604a980b407d 61 fields · synced Jun 18, 2026
- FDA UDI f3aeee85-6a2f-40d6-aa7d-0e6e8d391038 32 fields · synced May 30, 2026