Identity
- Trade Name
- PureSperm 90 EUDAMED
- Device Name
- PureSperm 90 EUDAMED
- Model / Reference
- PS90-100 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 07350025610405 EUDAMED
- Basic UDI-DI
- B-07350025610405 EUDAMED
- EMDN Code
- U08020502 MATERIALS/SOLUTIONS FOR PREPARATION/HANDLING FOR ASSISTED REPRODUCTION EUDAMED
Classification
- Device Class
- Class III EUDAMED
- Market of Registration
- Sweden EUDAMED
Clinical & Handling
Sterile
Yes
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
Reprocessed
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
PureSperm 90 by Nidacon International Ab — Class III — MDD — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | B-07350025610405 | Class III | Active |
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Manufacturer
- Manufacturer
- Nidacon International AB
- EUDAMED SRN
- SE-MF-000001933
Sources (1)
- EUDAMED d58324d4-bfc4-49d7-89af-e92cbffe19d9 61 fields · synced Jun 19, 2026