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ASP Multi TITANIUM 320
EUDAMEDFDA UDIFDA 510(k)Class IIa (EU MDR)
Ref 113203510(k) K060392
by Sedatelec
Identity
- Trade Name
- ASP Multi TITANIUM 320 EUDAMEDASP FDA UDI
- Generic Name
- Acupuncture needle, single-use FDA UDI
- Device Name
- ASPM TITANIUM 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
- 113203 EUDAMEDASPMT320 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
- 113203 FDA UDI
- Primary DI / UDI-DI
- 03760262493428 EUDAMEDFDA UDI
- Basic UDI-DI
- 3760262490106Y3 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 TITANIUM 320 by Sedatelec — Class IIa — FDA_510K, MDR — listed in EUDAMED, FDA GUDID, FDA 510(k) — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
United States Active
FDA_510K
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K060392 | Class IIa | Active |
| EUDAMED | European Union | CE/MDR | 3760262490106Y3 | Class IIa | Active |
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Manufacturer
- Manufacturer
- Sedatelec
- EUDAMED SRN
- FR-MF-000020946
Sources (3)
- EUDAMED 191d8a51-97f7-4ca3-a950-2fb0e9b30a11 85 fields · synced Jun 18, 2026
- FDA UDI b2f20367-3b13-475f-a93d-d84f48648df9 37 fields · synced May 30, 2026
- FDA 510(k) K060392 1 fields · synced May 18, 2026