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 1615 Speed Pak: coated acupuncture needles with copper-wire handle|without guide tube|Packaging: 5 needles per blister|Size: Gauge 2(x 0.6") / 0.16 x 15 mm|Color code: light brown|Sales unit: 1,000 pieces FDA UDI
Model / Reference: 5CB-Type 1615 Speed Pak FDA UDI
Description: TeWa 5CB-Type 1615 Speed Pak: coated acupuncture needles with copper-wire handle|without guide tube|Packaging: 5 needles per blister|Size: Gauge 2(x 0.6") / 0.16 x 15 mm|Color code: light brown|Sales unit: 1,000 pieces FDA UDI

Identifiers

Catalog Number: A012181 FDA UDI
Primary DI / UDI-DI: 04251282514266 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 — 15 Millimeter FDA UDI
Outer Diameter — 0.16 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
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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 c4413f22-0c7b-49f9-8b9e-73701c695503 37 fields · synced Jun 1, 2026