Identity
- Trade Name
- Disposable sampling swab FDA UDI
- Generic Name
- Oral/upper respiratory tract specimen collection swab IVD FDA UDI
- Device Name
- Disposable sampling swab EUDAMED
- Model / Reference
- NA EUDAMEDFDA UDI
Identifiers
- Primary DI / UDI-DI
- 06973069980054 EUDAMEDFDA UDI
- Basic UDI-DI
- 697306998DSSABSEOQW EUDAMED
- FDA Product Code
- KXG FDA UDI
- EMDN Code
- A1101 SAMPLE COLLECTION NEUTRAL SWABS EUDAMED
- GMDN Term
- Oral/upper respiratory tract specimen collection swab IVD 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
No
Serial Number
No
Expiration Date
No
Manufacturing Date
No
Category: General-purpose absorbent tip applicator/swab, single-use
Disposable sampling swab by Dalian Rongbang Medical Healthy Devices Co., Ltd. — Class I — MDR, FDA UDI — listed in EUDAMED, FDA GUDID
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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 | 697306998DSSABSEOQW | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Dalian Rongbang Medical Healthy Devices Co., Ltd
- EUDAMED SRN
- CN-MF-000022752
- Authorised Representative
- Lotus NL B.V. NL-AR-000000121
Sources (2)
- EUDAMED 88b838c2-a6d1-489e-9632-6c95ecfc1e15 61 fields · synced Jun 19, 2026
- FDA UDI 543af3b6-f12d-4870-8888-d027fe962804 32 fields · synced May 30, 2026