← Back to catalogue

Enhance-S Plus HEPES HTF

FDA UDI

Class II (US FDA UDI)

by Vitrolife AB

Identity

Trade Name
Enhance-S Plus HEPES HTF FDA UDI
Generic Name
Spermatozoa/semen motility medium supplement FDA UDI
Device Name
1-(100ml/lower%) & 1-(100ml/upper%) FDA UDI
Model / Reference
15250 FDA UDI
Description
1-(100ml/lower%) & 1-(100ml/upper%) FDA UDI

Identifiers

Primary DI / UDI-DI
00805360016773 FDA UDI
510(k) Number
K030116 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

Yes

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

Dimensions & Sizes

Size
Total Volume — 100 Milliliter FDA UDI

Category: Spermatozoa/semen motility medium supplement

Enhance-S Plus HEPES HTF by Vitrolife AB — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Spermatozoa/semen motility medium supplement.

Cleared under the same submission

K030116 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer
Vitrolife AB

Sources (1)

  • FDA UDI eb5d8b97-bff4-4734-9acf-563e81a2bcaa 35 fields · synced May 31, 2026