Microlet®next

FDA UDI

Class II (US FDA UDI)

by Ascensia Diabetes Care Us Inc.

Identity

Trade Name: MICROLET®NEXT FDA UDI
Generic Name: Manual blood lancing device, reusable FDA UDI
Device Name: Lancing Device. 1 Kit: 1 MICROLET®NEXT lancing device with adjustable endcap; 5 MICROLET® sterile lancets, coated with silicone. FDA UDI
Model / Reference: 6702 FDA UDI
Description: Lancing Device. 1 Kit: 1 MICROLET®NEXT lancing device with adjustable endcap; 5 MICROLET® sterile lancets, coated with silicone. FDA UDI

Identifiers

Catalog Number: 85139940 FDA UDI
Primary DI / UDI-DI: 00301936702014 FDA UDI
510(k) Number: K220633 FDA UDI
FDA Product Code: QRL FDA UDI
GMDN Term: Manual blood lancing device, reusable FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 878.4850 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

FDA UDI

Single Use

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

FDA UDI

Over-the-Counter

Yes

FDA UDI

Convenience Kit

Yes

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: Manual blood lancing device, reusable

Microlet®next by Ascensia Diabetes Care Us Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Manual blood lancing device, reusable.

Pylo Health — PREVOUNCE HEALTH, INC · Class II
Accu-Chek Fastclix — ROCHE DIABETES CARE, INC. · Class II
BEWELL CONNECT MyGluco Lancing device — Visiomed Group SA · Class II
Autolet — OWEN MUMFORD USA INCORPORATED · Class II
Lancing Device — Shandong Lianfa Medical Plastic Products CO., LTD · Class II
TeleRPM & Chronica — Mio Labs Inc.
Accu-Chek Safe-T-Pro — ROCHE DIABETES CARE, INC. · Class II
Accu-Chek Fastclix — ROCHE DIABETES CARE, INC. · Class II

Cleared under the same submission

K220633 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: Ascensia Diabetes Care Us Inc.

Sources (1)

FDA UDI 90d4a07d-393e-476e-805a-f3bd0cb7bfc3 36 fields · synced Jun 8, 2026