Identity
- Trade Name
- MEIDIKE GENE FDA UDI
- Generic Name
- Oral/upper respiratory tract specimen collection swab FDA UDI
- Model / Reference
- MFS-98000KQ FDA UDI
Identifiers
- Primary DI / UDI-DI
- 06974931650013 FDA UDI
- FDA Product Code
- KXG FDA UDI
- GMDN Term
- Oral/upper respiratory tract specimen collection swab FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 880.6025 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
FDA UDI
Single Use
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
No
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Oral/upper respiratory tract specimen collection swab
Meidike Gene by Medico Technology Co., Ltd — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Oral/upper respiratory tract specimen collection swab.
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- Cultura™ — Merit Medical Systems, Inc. · Class I
- Sterile Specimen Collection Swab — APPLIED MEDICAL RESOURCES CORP. · Class I
- Rhinostics, Inc. — Rhinostics Inc · Class I
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Medico Technology Co., Ltd
Sources (1)
- FDA UDI dbd00a9e-b011-4ad5-9abf-f1633705b411 32 fields · synced Jun 8, 2026