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Disposable Virus Sampling Swab Kits
EUDAMEDFDA UDIClass A (EU MDR)
Ref ST7001-2Model ST7001-0, ST7001-1, ST7001-2, ST8001-0, ST8001-1, ST8001-2, ST9001-0, ST9001-1, ST9001-2Ref ST7001-0Ref ZK1500-4Model ZK1000-1, ZK1500-1, ZK1000-5, ZK1500-2, ZK1500-3, ZK1500-4, ZK1500-5Ref ZK1000-5Ref ST7001-1Ref ST8001-2Ref ZK1500-3Ref ST9001-0Ref ST8001-1Ref ZK1000-1Ref ZK1500-5
Identity
- Trade Name
- BioTeke FDA UDI
- Generic Name
- General specimen collection kit IVD, clinical FDA UDI
- Device Name
- Disposable Virus Sampling Swab Kits EUDAMED
- Model / Reference
- ST7001-0, ST7001-1, ST7001-2, ST8001-0, ST8001-1, ST8001-2, ST9001-0, ST9001-1, ST9001-2 EUDAMEDST7001-2 EUDAMEDFDA UDIST7001-0 EUDAMEDZK1000-1, ZK1500-1, ZK1000-5, ZK1500-2, ZK1500-3, ZK1500-4, ZK1500-5 EUDAMEDZK1500-4 EUDAMEDZK1000-5 EUDAMEDST7001-1 EUDAMEDST8001-2 EUDAMEDZK1500-3 EUDAMEDST9001-0 EUDAMEDST8001-1 EUDAMEDZK1000-1 EUDAMEDZK1500-5 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06974541563048 EUDAMEDFDA UDI06974541564854 EUDAMED06974541564816 EUDAMED06974541564793 EUDAMED06974541564861 EUDAMED06974541564892 EUDAMED06974541564809 EUDAMED06974541564908 EUDAMED06974541564885 EUDAMED06974541564779 EUDAMED06974541564823 EUDAMED
- Basic UDI-DI
- 697454156004KZ EUDAMED697454156008L9 EUDAMED
- FDA Product Code
- JSG FDA UDI
- EMDN Code
- W05019099 SAMPLES COLLECTION DEVICES - OTHER EUDAMEDW0105900103 SUPPLEMENTAL NA REAGENTS EUDAMED
- GMDN Term
- General specimen collection kit IVD, clinical FDA UDI
Classification
- Device Class
- Class A EUDAMEDClass I FDA UDI
- Regulation Number
- 866.2300 FDA UDI
- Market of Registration
- Austria EUDAMEDFinland EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Microbial Substances
No
EUDAMED
Reagent
Yes
EUDAMED
Self Testing
No
EUDAMED
Near-Patient Testing
No
EUDAMED
Professional Testing
No
EUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
No
EUDAMED
New Device
No
EUDAMED
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
Disposable Virus Sampling Swab Kits by Bioteke Corporation (Wuxi) Co., Ltd. — Class A — IVDR, FDA UDI — listed in EUDAMED, FDA GUDID
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/IVDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/IVDR | 697454156004KZ | Class A | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class A | Pending data |
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Manufacturer
- Manufacturer
- BioTeke Corporation（Wuxi）Co., Ltd
- EUDAMED SRN
- CN-MF-000007517
- Authorised Representative
- SUNGO Europe B.V. NL-AR-000000247
Sources (13)
- EUDAMED d852d75b-4f2c-49a5-9f02-572b06faba04 61 fields · synced Oct 6, 2026
- FDA UDI d4f8a2b0-9e2f-4cb1-9815-8ea71d85dd80 32 fields · synced May 30, 2026
- EUDAMED 4b320f47-22e8-467d-925f-171ab6042aed 61 fields · synced Jun 18, 2026
- EUDAMED ed64ffe9-93f3-404d-88b2-b6c8a4bbc34f 61 fields · synced Jul 9, 2026
- EUDAMED 0a776f60-b007-493f-aee1-e6a4ea2918fa 61 fields · synced Jul 9, 2026
- EUDAMED aabc1eab-7e78-494b-8a5a-d538bad7a427 61 fields · synced Jul 9, 2026
- EUDAMED f7107d2e-813e-4716-b610-ae05462a63be 61 fields · synced Jul 10, 2026
- EUDAMED 13f0d736-17e9-4630-8101-c190201d03f7 61 fields · synced Jul 15, 2026
- EUDAMED d1e351f9-84a4-40ac-b2ec-e7158b2cc88c 61 fields · synced Jul 15, 2026
- EUDAMED de2c4d09-6537-44ef-a2c2-f1ddd1698423 61 fields · synced Jul 25, 2026
- EUDAMED b13b7884-4083-4cf4-97ea-728c4aa0f2da 61 fields · synced Jul 26, 2026
- EUDAMED dcd5f09e-0139-493b-a398-e39e3eb4321c 61 fields · synced Aug 1, 2026
- EUDAMED f44284ec-c23f-477a-9266-a78da2dde11a 61 fields · synced Sep 18, 2026