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Sil-Select Plus with phenol red and gentamicin - 8 preparations
EUDAMEDClass III (EU MDR)
Ref SIP008PRG
by FertiPro
Identity
- Trade Name
- Sil-Select Plus with phenol red and gentamicin - 8 preparations EUDAMED
- Device Name
- Sil-Select Plus EUDAMED
- Model / Reference
- SIP008PRG EUDAMED
Identifiers
- Primary DI / UDI-DI
- 05411967002597 EUDAMED
- Basic UDI-DI
- 5411967DENSGPROPACK1V6 EUDAMED
- EMDN Code
- U08020502 MATERIALS/SOLUTIONS FOR PREPARATION/HANDLING FOR ASSISTED REPRODUCTION EUDAMED
Classification
- Device Class
- Class III EUDAMED
- Medical Purpose
- Density Gradient media are used as sperm preparation method for intrauterine insemination (IUI), in vitro fertilization (IVF), intra-cytoplasmic sperm injection (ICSI), and related assisted reproductive technologies (ART). EUDAMED
Clinical & Handling
Sterile
Yes
EUDAMED
Sil-Select Plus with phenol red and gentamicin - 8 preparations by FertiPro — Class III — MDR — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 5411967DENSGPROPACK1V6 | Class III | Active |
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Manufacturer
- Manufacturer
- FertiPro
- EUDAMED SRN
- BE-PR-000000330
Sources (1)
- EUDAMED 0e0268de-2964-412f-812f-66beb3228e07 61 fields · synced Jul 29, 2026