BD Surepath Sample Collection Kit
FDA UDIEUDAMEDClass II (US FDA UDI)
Identity
- Trade Name
- BD SurePath™ EUDAMEDBD Surepath Sample Collection Kit FDA UDI
- Generic Name
- Urogenital specimen collection kit IVD, clinical FDA UDI
- Device Name
- Medscand® Sample Collection Kit EUDAMEDCervical cytology sampling kit FDA UDI
- Model / Reference
- 490525 EUDAMEDFDA UDI70124-001 EUDAMED
- Description
- Cervical cytology sampling kit FDA UDI
Identifiers
- Primary DI / UDI-DI
- 60888937021402 EUDAMED20888937021404 FDA UDI
- Basic UDI-DI
- 0888937TD006ns2S EUDAMED
- 510(k) Number
- K861389 FDA UDI
- FDA Product Code
- HHT FDA UDI
- EMDN Code
- W02020502 CERVICAL SCREENING SYSTEMS EUDAMED
- GMDN Term
- Urogenital specimen collection kit IVD, clinical FDA UDI
Classification
- Device Class
- Class I EUDAMEDClass II FDA UDI
- Regulation Number
- 884.4530 FDA UDI
- Market of Registration
- Netherlands EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
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
Yes
Over-the-Counter
No
Convenience Kit
Yes
Combination Product
No
HCT/P
No
Premarket Exempt
No
Lot / Batch Number
Yes
Serial Number
No
Expiration Date
Yes
Manufacturing Date
No
Category: Urogenital specimen collection kit IVD, clinical
BD Surepath Sample Collection Kit by CooperSurgical, Inc. — Class II — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as Urogenital specimen collection kit IVD, clinical.
- BD ProbeTec™ Qx Collection Kit for Endocervical or Lesion Specimens — BECTON DICKINSON AND COMPANY · Class II
- BD SurePath™ GYN Preservative Vial Kit with Brush/Spatula — BECTON DICKINSON AND COMPANY · Class III
- digene® HC2 DNA Collection Device — QIAGEN Sciences LLC · Class II
- Aptima® — Hologic, Inc. · Class II
- BD SurePath™ GYN Preservative Vial Kit with Cervex-Brush — BECTON DICKINSON AND COMPANY · Class III
- BD SurePath™ GYN Preservative Vial Kit with Cervex-Brush Combi — BECTON DICKINSON AND COMPANY · Class III
- BD Copan FLOQSwabs for HPV Self Collection — BECTON DICKINSON AND COMPANY · Class III
- Rapid fFN — Hologic, Inc. · Class I
Cleared under the same submission
Authorization Coverage (2 countries)
Regulatory Authorizations
MDR
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class II | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- CooperSurgical, Inc.
Sources (2)
- FDA UDI c398ea31-0430-40b7-b907-224448b223d0 34 fields · synced Jun 20, 2026
- EUDAMED e773f84e-45e9-4100-924d-3d7d27d2c9a0 61 fields · synced Jun 20, 2026