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Human Chorionic Gonadotropin Combo Rapid Test (20/20mIU)
EUDAMEDClass B (EU MDR)
Ref Format(Strip):A02600;Format(Device):A03010Model Format(Strip):A02600150, A02600250;Format(Device):A03010125, A03010140, A03010225, A03010240Ref HCG-C11 HCG-C23
Identity
- Trade Name
- Human Chorionic Gonadotropin Combo Rapid Test (20/20mIU) EUDAMEDHuman Chorionic Gonadotropin Combo Rapid Test EUDAMED
- Device Name
- Human Chorionic Gonadotropin Combo Rapid Test (20/20mIU) EUDAMEDHuman Chorionic Gonadotropin Combo Rapid Test EUDAMED
- Model / Reference
- Format(Strip):A02600150, A02600250;Format(Device):A03010125, A03010140, A03010225, A03010240 EUDAMEDFormat(Strip):A02600;Format(Device):A03010 EUDAMEDHCG-C11 HCG-C23 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06952804833459 EUDAMED06952804813864 EUDAMED
- Basic UDI-DI
- 69528048A030100WF EUDAMEDB-06952804813864 EUDAMED
- EMDN Code
- W0102050205 TOTAL HUMAN CHORIONIC GONADOTROPIN EUDAMEDW0102160302 HCG - RT & POC EUDAMED
Classification
- Device Class
- Class B EUDAMEDClass IVD General EUDAMED
- Market of Registration
- Spain EUDAMEDNetherlands EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
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
Yes
EUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
No
EUDAMED
New Device
No
EUDAMED
Human Chorionic Gonadotropin Combo Rapid Test (20/20mIU) by Assure Tech. (hangzhou) Co., Ltd. — Class B — IVDD, IVDR — listed in EUDAMED
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/IVDD
European Union Active
CE/IVDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/IVDD | 69528048A030100WF | Class B | Active |
| EUDAMED | European Union | CE/IVDR | 69528048A030100WF | Class B | Active |
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Manufacturer
- Manufacturer
- Assure Tech. (Hangzhou) Co., Ltd.
- EUDAMED SRN
- CN-MF-000002170
- Authorised Representative
- CMC Medical Devices & Drugs SL ES-AR-000000293
Sources (3)
- EUDAMED e985e220-a51f-4104-9c00-09a608c2d479 61 fields · synced Jul 17, 2026
- EUDAMED 7bf37bbf-7947-437c-8378-1f0769acbbe4 61 fields · synced May 19, 2026
- EUDAMED e985e220-a51f-4104-9c00-09a608c2d479-1 61 fields · synced Jun 10, 2026