Identity
- Trade Name
- ASP Multi CLASSIC 120 EUDAMEDASP FDA UDI
- Generic Name
- Acupuncture needle, single-use FDA UDI
- Device Name
- ASPM Classic EUDAMEDThe ASP Multi, 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 5 needles encased in a plastic injector. The injector itself consists of a needle guide which facilitates positioning of the ASP 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. FDA UDI
- Model / Reference
- 113204 EUDAMEDASPMA120 FDA UDI
- Description
- The ASP Multi, 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 5 needles encased in a plastic injector. The injector itself consists of a needle guide which facilitates positioning of the ASP 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. FDA UDI
Identifiers
- Catalog Number
- 113204 FDA UDI
- Primary DI / UDI-DI
- 03760262493435 EUDAMEDFDA UDI
- Basic UDI-DI
- 3760262490104XX 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 EUDAMEDClass II FDA UDI
- Regulation Number
- 880.5580 FDA UDI
- Market of Registration
- France EUDAMED
- Commercial Distribution
- 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
ASP Multi CLASSIC 120 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
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 3760262490104XX | Class IIa | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIa | Pending data |
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Manufacturer
- Manufacturer
- Sedatelec
- EUDAMED SRN
- FR-MF-000020946
Sources (2)
- EUDAMED 724bdce0-4b32-4b92-a4c4-600b541ef92e 61 fields · synced Jul 28, 2026
- FDA UDI 3ee67c52-e810-42b7-bebc-ee6408eb3f63 37 fields · synced May 30, 2026