← Back to catalogue
Human Papillomavirus Self Sample Collection Kit
EUDAMEDClass A (EU MDR)
Ref PH03010J01T2001Ref PH03010K06C2001Ref PG03010I04C2001Ref PH03010I01T2001
Identity
- Device Name
- Human Papillomavirus Self Sample Collection Kit EUDAMED
- Model / Reference
- PH03010J01T2001 EUDAMEDPH03010K06C2001 EUDAMEDPG03010I04C2001 EUDAMEDPH03010I01T2001 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06970895471763 EUDAMED06970895478601 EUDAMED06970895478656 EUDAMED06970895470353 EUDAMED
- Basic UDI-DI
- 697089547HPVSSC00X5 EUDAMED
- EMDN Code
- A1102 SAMPLE COLLECTION SWABS WITH TRANSPORT MEDIUM EUDAMED
Classification
- Device Class
- Class A EUDAMED
- Market of Registration
- Belgium EUDAMEDHungary EUDAMEDNetherlands EUDAMEDBulgaria EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Microbial Substances
No
EUDAMED
Reagent
Yes
EUDAMED
Self Testing
Yes
EUDAMED
Near-Patient Testing
No
EUDAMED
Professional Testing
No
EUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
No
EUDAMED
New Device
No
EUDAMED
Category: General-purpose absorbent tip applicator/swab, single-use
Human Papillomavirus Self Sample Collection Kit by Jiangsu Mole Bioscience Co., LTD. — Class A — IVDR — listed in EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as General-purpose absorbent tip applicator/swab, single-use.
- Disposable Sterile Swabs — Hangzhou Yiguoren Biotechnology Co.,Ltd. · Class I
- NATIONAL HOSPITAL PACKAGING — Surgi-Pak, Inc. · Class I
- ESCOB. PS FLOCK NASOF. 80MM EN TUBO — Deltalab, S.L. · Class IIa
- Disposable sampling swab — Jiangsu HanHeng Medical Technology Co., Ltd. · Class I
- Microbrush — YOUNG MICROBRUSH LLC · Class I
- CITOTEST — CITOTEST LABWARE MANUFACTURING CO.,LTD · Class I
- ESCOB.FLOCK NASOF. 80MM FLOW — Deltalab, S.L. · Class I
- CITOTEST — CITOTEST LABWARE MANUFACTURING CO.,LTD · Class I
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/IVDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/IVDR | 697089547HPVSSC00X5 | Class A | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Jiangsu Mole Bioscience Co., LTD.
- EUDAMED SRN
- CN-MF-000001539
- Authorised Representative
- SUNGO Europe B.V. NL-AR-000000247
Sources (4)
- EUDAMED d761d9f6-c8ed-4004-8f7c-b14dbec3f095 61 fields · synced Aug 2, 2026
- EUDAMED fe52cc06-62f0-4021-9736-4672b7e3bac9 61 fields · synced May 11, 2026
- EUDAMED c7172906-4100-4e72-a567-8ddcd720d0b8 61 fields · synced May 18, 2026
- EUDAMED b8c6c6bd-82a7-4f1b-af29-5205298953ff 61 fields · synced May 19, 2026