Identity
- Trade Name
- ASPIRATION NEEDLE EUDAMEDASPI FDA UDI
- Generic Name
- Needle guide, single-use FDA UDI
- Device Name
- PUNCTURE NEEDLES EUDAMEDASPI Aspiration Needle 22G,30cm FDA UDI
- Model / Reference
- ASPI 22/30 EUDAMEDASPI Aspiration Needle FDA UDI
- Description
- ASPI Aspiration Needle 22G,30cm FDA UDI
Identifiers
- Catalog Number
- ASPI22/30 FDA UDI
- Primary DI / UDI-DI
- 00812261016597 EUDAMEDFDA UDI
- Basic UDI-DI
- 081226101PNS020UW EUDAMED
- FDA Product Code
- MQE FDA UDI
- EMDN Code
- A019013 PERCUTANEOUS NEEDLES EUDAMED
- GMDN Term
- Needle guide, single-use FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA UDI
- Regulation Number
- 884.6100 FDA UDI
- Market of Registration
- Germany 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
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
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Needle guide, single-use
Aspi by Allwin Medical Devices, Inc. — Class II — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
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Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Unknown
MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class II | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Allwin Medical Devices, Inc.
Sources (2)
- FDA UDI 935e9d35-f14e-413e-b5b6-bd71c2c508ba 35 fields · synced Jul 25, 2026
- EUDAMED 7cc76447-54bf-4153-a216-000017c1c67b 61 fields · synced Jul 25, 2026