Tewa

FDA UDI

Class II (US FDA UDI)

by asia-med GmbH

Identity

Trade Name: TEWA FDA UDI
Generic Name: Acupuncture needle, single-use FDA UDI
Device Name: TeWa 5CB-Type 2550 Speed Pak: coated acupuncture needles with copper-wire handle|without guide tube|Packaging: 5 needles per blister|Size: Gauge 5(x 2.0") / 0.25 x 50 mm|Color code: purple|Sales unit: 1,000 pieces FDA UDI
Model / Reference: 5CB-Type 2550 Speed Pak FDA UDI
Description: TeWa 5CB-Type 2550 Speed Pak: coated acupuncture needles with copper-wire handle|without guide tube|Packaging: 5 needles per blister|Size: Gauge 5(x 2.0") / 0.25 x 50 mm|Color code: purple|Sales unit: 1,000 pieces FDA UDI

Identifiers

Catalog Number: A000404 FDA UDI
Primary DI / UDI-DI: 04251282508920 FDA UDI
FDA Product Code: MQX FDA UDI
GMDN Term: Acupuncture needle, single-use FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 880.5580 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

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

Dimensions & Sizes

Size: Length — 50 Millimeter FDA UDI
Outer Diameter — 0.25 Millimeter FDA UDI

Category: Acupuncture needle, single-use

Tewa by asia-med GmbH — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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AcuZone — Wujiang City ShenLing Medical Device Co., Ltd · Class II
Millennia Bulk Acupuncture Needle — UPC MEDICAL SUPPLIES, INC. · Class II
Peace Speed-Pak Acupuncture Needles — Acu Market · Class II
STERILE ACUPUNCTURE NEEDLES FOR SINGLE USE — Changchun AIK Medical Devices Co., Ltd. · Class II

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: asia-med GmbH

Sources (1)

FDA UDI 4700262f-0e0d-4909-b247-bfbc27d55186 37 fields · synced Jun 8, 2026