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ASP Original TITANIUM 80

EUDAMEDFDA UDI

Class IIa (EU MDR)

Ref 110626

by Sedatelec

Identity

Trade Name
ASP Original TITANIUM 80 EUDAMED
ASP FDA UDI
Generic Name
Acupuncture needle, single-use FDA UDI
Device Name
ASP TITANIUM EUDAMED
The ASP Original, Semi-Permanent Needle, is an original device allowing a small 2 mm needle to be implanted into the points on the pinna of the ear. It consists of a needle encased in a plastic injector. The injector itself consists of a needle guide which facilitates positioning of the ASP Original exactly on the selected point, and a plunger generating the impulse required for implantation. A stimulation magnet is present on the tip of the injector and may be used to activate the action of the needle or to directly stimulate the point which is to be treated. A hypoallergenic adhesive disc can also be positioned in order to protect the needle. The ASP Titanium is a massive medical grade 4 titanium needle, it has a maximum level of biocompatibility. It is for use with high-risk patient: diabetic, immunodeficient or with multiple allergies. It can be stay in place during MRI examination. FDA UDI
Model / Reference
110626 EUDAMED
ASPT80 FDA UDI
Description
The ASP Original, Semi-Permanent Needle, is an original device allowing a small 2 mm needle to be implanted into the points on the pinna of the ear. It consists of a needle encased in a plastic injector. The injector itself consists of a needle guide which facilitates positioning of the ASP Original exactly on the selected point, and a plunger generating the impulse required for implantation. A stimulation magnet is present on the tip of the injector and may be used to activate the action of the needle or to directly stimulate the point which is to be treated. A hypoallergenic adhesive disc can also be positioned in order to protect the needle. The ASP Titanium is a massive medical grade 4 titanium needle, it has a maximum level of biocompatibility. It is for use with high-risk patient: diabetic, immunodeficient or with multiple allergies. It can be stay in place during MRI examination. FDA UDI

Identifiers

Catalog Number
110626 FDA UDI
Primary DI / UDI-DI
03760262490540 EUDAMEDFDA UDI
Basic UDI-DI
3760262490103XV EUDAMED
510(k) Number
K060392 FDA UDI
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
France EUDAMED
Commercial Distribution
Not 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

No

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

No

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

Yes

FDA UDI
MRI Safety
MR Safe FDA UDI

ASP Original TITANIUM 80 by Sedatelec — Class IIa — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS

Authorization Coverage (2 countries)

Regulatory Authorizations

European Union Active

CE/MDR

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Sedatelec
EUDAMED SRN
FR-MF-000020946

Sources (2)

  • EUDAMED b13caa5e-6988-4e41-82c6-a840035b401b 61 fields · synced Jul 14, 2026
  • FDA UDI b464bf66-a1f4-4c22-b0a9-b451562d7ce1 38 fields · synced May 30, 2026