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 ID-Type 1205 Intradermal needle: uncoated TeWa intradermal acupuncture needles with with a ring handle (hinai-shin).|Packaging: 1 needle per blister|Size: Gauge 02(x 0.2") / 0.12 x 5 mm|Color code: dark green|Sales unit: 100 pieces FDA UDI
Model / Reference: ID-Type 1205 Intradermal needle FDA UDI
Description: TeWa ID-Type 1205 Intradermal needle: uncoated TeWa intradermal acupuncture needles with with a ring handle (hinai-shin).|Packaging: 1 needle per blister|Size: Gauge 02(x 0.2") / 0.12 x 5 mm|Color code: dark green|Sales unit: 100 pieces FDA UDI

Identifiers

Catalog Number: A000561 FDA UDI
Primary DI / UDI-DI: 04251282511593 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 — 5 Millimeter FDA UDI
Outer Diameter — 0.12 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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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 569d837a-c0c0-45ef-b880-f715a4721fb7 37 fields · synced Jun 8, 2026