Identity
- Trade Name
- HBA® EUDAMED
- Device Name
- HBA® Sperm-Hyaluronan Binding Assay EUDAMED
- Model / Reference
- BCT-HBA-10 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 20888937025839 EUDAMED
- Basic UDI-DI
- 08889370TD104PW EUDAMED
- EMDN Code
- W05039099 DEVICES FOR SAMPLES ANALYSES - OTHER EUDAMED
Classification
- Device Class
- Class A EUDAMED
- Market of Registration
- Netherlands EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Microbial Substances
No
EUDAMED
Reagent
No
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
Hba® by CooperSurgical, Inc. — Class A — IVDR — listed in EUDAMED — regulatory data on deviCERTS
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 | 08889370TD104PW | Class A | Active |
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Manufacturer
- Manufacturer
- CooperSurgical, Inc.
- EUDAMED SRN
- US-MF-000002607
- Authorised Representative
- CooperSurgical Distribution B.V. NL-AR-000000059
Sources (1)
- EUDAMED 608171fc-b5d6-47cc-bc7e-27bf644c1322 61 fields · synced Jun 19, 2026