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Rapid Sperm Morphological Stain (Diff-Quik method)
EUDAMEDClass A (EU MDR)
Ref DQS-010Ref DQS-020Ref DQS-320Ref DQS-030
Identity
- Trade Name
- Rapid Sperm Morphological Stain (Diff-Quik method) EUDAMED
- Device Name
- Reproductive Medicine EUDAMED
- Model / Reference
- DQS-010 EUDAMEDDQS-020 EUDAMEDDQS-320 EUDAMEDDQS-030 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04719889117858 EUDAMED04719889117865 EUDAMED04719889117841 EUDAMED04719889117872 EUDAMED
- Basic UDI-DI
- 471988911ReproductiveJ7 EUDAMED
- EMDN Code
- W01030799 HISTOLOGY / CYTOLOGY REAGENTS - OTHER EUDAMED
Classification
- Device Class
- Class A 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
Rapid Sperm Morphological Stain (Diff-Quik method) by BaSO Biotech Co., LTD.. — 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 | 471988911ReproductiveJ7 | Class A | Active |
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Manufacturer
- Manufacturer
- BaSO Biotech Co., LTD..
- EUDAMED SRN
- TW-MF-000018809
- Authorised Representative
- CMC Medical Devices & Drugs SL ES-AR-000000293
Sources (4)
- EUDAMED c77091e5-bbdf-4433-9708-48b92645b75b 61 fields · synced Jul 29, 2026
- EUDAMED 5f136d38-52a6-442c-8817-6148f7a1714b 61 fields · synced May 16, 2026
- EUDAMED 2b81283c-537c-4044-87b7-fc44233baa38 61 fields · synced May 19, 2026
- EUDAMED dbc6abc9-2dc0-4111-b07a-fdd0d5aa8743 61 fields · synced May 19, 2026