AutoKeeper®

EUDAMEDFDA UDIFDA 510(k)

Class IIa (EU MDR)

Ref 32Gx4mm(R)Model 25 models including '29Gx8mm(G)'

by Medexel Co., Ltd.

Identity

Trade Name: AutoKeeper® EUDAMED
Autokeeper FDA UDI
Generic Name: Hypodermic needle, single-use FDA UDI
Device Name: Safety Pen Needle EUDAMED
Autokeeper® Safety Pen Needles are single use, sterile, medical devices designed to be used in conjunction with insulin pen injectors. Pen needles are used by consumers, caregivers and health care professionals. They are offered in six gauge sizes (29G, 30G, 31G, 32G, 33G and 34G) and lengths (4mm, 5mm, 6mm and 8mm). This device is sterile (EO gas sterilization). Additionally, the attached safety shield automatically locks in place and is intended to help reduce the occurrence of accidental needle sticks from the patient end of the needle. The shield also serves to hide the needle before and after injection. This device is assembly consists of Sterile cap, Needle cap, Middle cap, Spring, Needle, Safety shield, hub and sterile paper. FDA UDI
Model / Reference: 25 models including '29Gx8mm(G)' EUDAMED
32Gx4mm(R) EUDAMED
Safety Pen Needle 31G x 6mm 100PCS FDA UDI
Description: Autokeeper® Safety Pen Needles are single use, sterile, medical devices designed to be used in conjunction with insulin pen injectors. Pen needles are used by consumers, caregivers and health care professionals. They are offered in six gauge sizes (29G, 30G, 31G, 32G, 33G and 34G) and lengths (4mm, 5mm, 6mm and 8mm). This device is sterile (EO gas sterilization). Additionally, the attached safety shield automatically locks in place and is intended to help reduce the occurrence of accidental needle sticks from the patient end of the needle. The shield also serves to hide the needle before and after injection. This device is assembly consists of Sterile cap, Needle cap, Middle cap, Spring, Needle, Safety shield, hub and sterile paper. FDA UDI

Identifiers

Primary DI / UDI-DI: 08809445831390 EUDAMEDFDA UDI
Basic UDI-DI: B-08809445831390 EUDAMED
510(k) Number: K172095 FDA UDI
FDA Product Code: FMI FDA UDI
EMDN Code: A0101010201 HYPODERMIC PEN NEEDLES, WITH SAFETY SYSTEMS EUDAMED
GMDN Term: Hypodermic needle, single-use FDA UDI

Classification

Device Class: Class IIa EUDAMED
Class II FDA UDI
Regulation Number: 880.5570 FDA UDI
Market of Registration: Germany EUDAMED
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

EUDAMEDFDA UDI

Single Use

Yes

FDA UDI

Implantable

EUDAMEDFDA UDI

Reusable

EUDAMED

Contains Latex

EUDAMEDFDA UDI

Reprocessed

EUDAMED

Human-derived

EUDAMED

Human Tissues

EUDAMED

Animal Tissues

EUDAMED

Administering Medicine

EUDAMED

Measuring Function

EUDAMED

Incorporates Medicinal Product

EUDAMED

Prescription Use

FDA UDI

Over-the-Counter

Yes

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

Dimensions & Sizes

Size: Length — 4 Millimeter FDA UDI
Needle Gauge — 29 Gauge FDA UDI

AutoKeeper® by Medexel Co., Ltd. — Class IIa — FDA_510K, MDD — listed in EUDAMED, FDA GUDID, FDA 510(k) — regulatory data on deviCERTS

Authorization Coverage (2 countries)

Regulatory Authorizations

United States Active

FDA_510K

European Union Active

CE/MDD

Source	Region	Type	Cert / Approval No.	Class	Status
FDA 510(k)	United States	FDA_510K	K172095	Class IIa	Active
EUDAMED	European Union	CE/MDD	B-08809445831390	Class IIa	Active

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Manufacturer

Manufacturer: Medexel Co., Ltd.
EUDAMED SRN: KR-MF-000016654
Authorised Representative: Medical Technology Promedt Consulting GmbH DE-AR-000000085

Sources (3)

EUDAMED d0e17810-5f56-4c5d-811a-5ba7db9f4d57 61 fields · synced Jul 27, 2026
FDA UDI a5632bf2-026d-4548-ae26-dee9c1c72512 36 fields · synced May 30, 2026
FDA 510(k) K172095 1 fields · synced May 18, 2026