Disposable sampling swab
EUDAMEDFDA UDIClass I (EU MDR)
Identity
- Trade Name
- Disposable sampling swab EUDAMEDiClean FDA UDI
- Generic Name
- General-purpose absorbent tip applicator/swab, single-use FDA UDI
- Device Name
- Disposable sampling swab EUDAMED
- Model / Reference
- CY-95000、CY-96000、CY-98000、CY-93050、CY-96001、CY-96002、CY-96003、CY-93051、CY-93052、CY-93053、CY-98000PS、CY-90001BF-22、CY-90001BF-35、CY-90001BF-80、CY-90001FS-80、CY-90001FS-100、CY-93050R、CY-90001-FS EUDAMEDCY-90001FS-80 EUDAMEDFDA UDI
Identifiers
- Primary DI / UDI-DI
- 06974488991416 EUDAMED16974488990409 FDA UDI
- Basic UDI-DI
- 697448899CY-95/6/8/3/8P5J 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
- France 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
No
Serial Number
No
Expiration Date
No
Manufacturing Date
No
Category: General-purpose absorbent tip applicator/swab, single-use
Disposable sampling swab by Huachenyang (Shenzhen) 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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Authorization Coverage (2 countries)
Regulatory Authorizations
CE/MDR
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 697448899CY-95/6/8/3/8P5J | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Huachenyang (Shenzhen) Technology Co., Ltd.
- EUDAMED SRN
- CN-MF-000020236
- Authorised Representative
- R Sight B.V. NL-AR-000010445
Sources (2)
- EUDAMED 129d1eb1-be1d-4b51-a362-c5ee14db33b5 61 fields · synced Sep 17, 2026
- FDA UDI 78ff9d4f-498a-43f5-adcd-c96a0f8b4ccf 32 fields · synced May 30, 2026