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Agupunt Aps

FDA UDI

Class II (US FDA UDI)

by Agu Punt Sl

Identity

Trade Name
AGUPUNT APS FDA UDI
Generic Name
Dry-needling needle FDA UDI
Device Name
Physiotherapy needles FDA UDI
Model / Reference
A1052P-T FDA UDI
Description
Physiotherapy needles FDA UDI

Identifiers

Primary DI / UDI-DI
08437016482629 FDA UDI
510(k) Number
K003748 FDA UDI
FDA Product Code
MQX FDA UDI
GMDN Term
Dry-needling needle 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

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

No

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

No

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Dry-needling needle

Agupunt Aps by Agu Punt Sl — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Dry-needling needle.

Cleared under the same submission

K003748 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Agu Punt Sl

Sources (1)

  • FDA UDI 9d3e3af4-900d-4e31-89e6-fd79c74bf66d 34 fields · synced Jun 8, 2026