Biopsy Pipette

FDA UDI

Class II (US FDA UDI)

by Vitrolife AB

Identity

Trade Name: Biopsy Pipette FDA UDI
Generic Name: User-induced micropipette FDA UDI
Model / Reference: 15123 FDA UDI

Identifiers

Primary DI / UDI-DI: 10805360016350 FDA UDI
510(k) Number: K991104 FDA UDI
FDA Product Code: MQH FDA UDI
GMDN Term: User-induced micropipette FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 884.6130 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

FDA UDI

Single Use

Yes

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

FDA UDI

Category: User-induced micropipette

Biopsy Pipette by Vitrolife AB — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as User-induced micropipette.

ICSI Pipette — Vitrolife Sweden AB · Class II
SFG Holding pipettes — SPECTRUM FERTILITY GROUP INC. · Class II
SFG Denuding pipettes — SPECTRUM FERTILITY GROUP INC. · Class II
Hatching Pipette — Vitrolife Sweden AB · Class II
Biopsy Pipette — Vitrolife Sweden AB · Class II
ICSI Pipette — Vitrolife Sweden AB · Class II
Holding Pipette — Vitrolife Sweden AB · Class II
Biopsy Pipette — Vitrolife Sweden AB · Class II

Cleared under the same submission

K991104 also covers:

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: Vitrolife AB

Sources (1)

FDA UDI d215fb8b-a3c9-4a0b-8ee6-a1897855c076 33 fields · synced May 30, 2026