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SEIRIN Acupuncture Needles

EUDAMEDFDA UDI

Class IIa (EU MDR)

Ref J-ProPak10 No.1(0.16) x 30mmRef J-ProPak10 No.1(0.16)x30mm

by Seirin Corporation

Identity

Trade Name
SEIRIN Acupuncture Needles EUDAMED
SEIRIN ACUPUNCTURE NEEDLE FDA UDI
Generic Name
Acupuncture needle, single-use FDA UDI
Device Name
SEIRIN Acupuncture Needles EUDAMED
The world's most popular acupuncture needle is now available in a user-friendly 10-pack. J-ProPak® 10 needles are made from the highest quality stainless steel and feature a lightweight, comfort grip, 2.0 x 20 mm plastic handle that is color coded for easy gauge identification. It continues the J-Type's tradition of gentle, painless and stress-free acupuncture but also features an easy open multi-pack, that allows for easy access to 10 needles at a time. The J-ProPak® 10 blister pack also converts into a functional dispenser that can rest on a treatment tray or other surface, keeping the needles sterile and easily accessible during treatment. Each blister pack contains 10 plastic handle needles and one polypropylene guide tube. Box of 100. FDA UDI
Model / Reference
J-ProPak10 No.1(0.16) x 30mm EUDAMED
J-ProPak10 No.1(0.16)x30mm EUDAMEDFDA UDI
Description
The world's most popular acupuncture needle is now available in a user-friendly 10-pack. J-ProPak® 10 needles are made from the highest quality stainless steel and feature a lightweight, comfort grip, 2.0 x 20 mm plastic handle that is color coded for easy gauge identification. It continues the J-Type's tradition of gentle, painless and stress-free acupuncture but also features an easy open multi-pack, that allows for easy access to 10 needles at a time. The J-ProPak® 10 blister pack also converts into a functional dispenser that can rest on a treatment tray or other surface, keeping the needles sterile and easily accessible during treatment. Each blister pack contains 10 plastic handle needles and one polypropylene guide tube. Box of 100. FDA UDI

Identifiers

Primary DI / UDI-DI
04547248171117 EUDAMEDFDA UDI
Basic UDI-DI
4547248SAN001RZ EUDAMED
B-04547248171117 EUDAMED
Unit of Use DI
24547248171111 EUDAMED
FDA Product Code
MQX FDA UDI
EMDN Code
A019002 ACUPUNCTURE NEEDLES EUDAMED
GMDN Term
Acupuncture needle, single-use FDA UDI

Classification

Device Class
Class IIa EUDAMED
Class II FDA UDI
Regulation Number
880.5580 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

No

EUDAMEDFDA UDI

Reusable

No

EUDAMED

Contains Latex

No

EUDAMEDFDA UDI

Reprocessed

No

EUDAMED

CMR Substance

Yes

EUDAMED

Human-derived

No

EUDAMED

Human Tissues

No

EUDAMED

Animal Tissues

No

EUDAMED

Endocrine Disruptor

No

EUDAMED

Administering Medicine

No

EUDAMED

Measuring Function

No

EUDAMED

Incorporates Medicinal Product

No

EUDAMED

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

Yes

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

Yes

FDA UDI

Dimensions & Sizes

Size
Outer Diameter — 0.16 Millimeter FDA UDI
Length — 30 Millimeter FDA UDI

SEIRIN Acupuncture Needles by Seirin Corporation — Class IIa — MDD, MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS

Authorization Coverage (2 countries)

Regulatory Authorizations

European Union Active

CE/MDD

European Union Active

CE/MDR

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Seirin Corporation
EUDAMED SRN
JP-MF-000012274
Authorised Representative
Emergo Europe B.V. NL-AR-000000116

Sources (3)

  • EUDAMED 37546285-5798-4af7-8447-02822ce638f6 61 fields · synced Jul 23, 2026
  • EUDAMED 1178da67-e3ee-4ae6-ad11-820f4707b104 61 fields · synced May 17, 2026
  • FDA UDI 5cf47610-3355-4be2-a510-617e3e70eb25 35 fields · synced May 30, 2026