Identity
- Trade Name
- Nidacon FDA UDI
- Generic Name
- Spermatozoa/semen motility medium supplement FDA UDI
- Device Name
- SpermCatch is a medium designed to modulate sperm motility in a physiological manner, to facilitate injecting a single spermatozoa into an oocyte (ICSI). ICSI is an available procedure in Assisted Reproduction Technology (ART). FDA UDI
- Model / Reference
- SpermCatch FDA UDI
- Description
- SpermCatch is a medium designed to modulate sperm motility in a physiological manner, to facilitate injecting a single spermatozoa into an oocyte (ICSI). ICSI is an available procedure in Assisted Reproduction Technology (ART). FDA UDI
Identifiers
- Catalog Number
- SC-100 FDA UDI
- Primary DI / UDI-DI
- 07350025610146 FDA UDI
- 510(k) Number
- K011607 FDA UDI
- FDA Product Code
- MQL FDA UDI
- GMDN Term
- Spermatozoa/semen motility medium supplement FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 884.6180 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Spermatozoa/semen motility medium supplement
Nidacon by Nidacon International AB — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Spermatozoa/semen motility medium supplement.
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- Enhance-S Plus — Vitrolife AB · Class II
- Enhance Sperm Wash w/ Gentamicin — Vitrolife AB · Class II
- Enhance-S Plus — Vitrolife AB · Class II
- Enhance-S Plus — Vitrolife AB · Class II
- SpermSelect Curve Kit — CooperSurgical, Inc. · Class II
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Nidacon International AB
Sources (1)
- FDA UDI ac65fee9-a7dd-499d-b559-38d14cbc669e 37 fields · synced May 30, 2026