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ACE Ovum Pickup Needle
EUDAMEDFDA UDIClass IIa (EU MDR)
Ref A-OVM-SL16/35-MModel ACE Single Lumen Ovum Pickup Needle,ACE-FL Single Lumen Ovum Pickup Needle with Flushing Line,ACE-M Manual Single Lumen Ovum Pickup Needle,OVUMPICK Double Lumen Ovum Pickup Needle,EAGLE Single Lumen Ovum Pickup Needle
Identity
- Trade Name
- ACE Ovum Pickup Needle EUDAMEDACE-M FDA UDI
- Generic Name
- IVF oocyte aspiration needle, single-use FDA UDI
- Device Name
- OVUM PICKUP NEEDLE EUDAMEDACE-M Manual Single Lumen Ovum Pickup Needle 16G, 35 cm FDA UDI
- Model / Reference
- ACE Single Lumen Ovum Pickup Needle,ACE-FL Single Lumen Ovum Pickup Needle with Flushing Line,ACE-M Manual Single Lumen Ovum Pickup Needle,OVUMPICK Double Lumen Ovum Pickup Needle,EAGLE Single Lumen Ovum Pickup Needle EUDAMEDA-OVM-SL16/35-M EUDAMEDACE-M Manual Single Lumen Ovum Pickup Needle 16G, 35 cm FDA UDI
- Description
- ACE-M Manual Single Lumen Ovum Pickup Needle 16G, 35 cm FDA UDI
Identifiers
- Catalog Number
- A-OVM-SL 16/35 - M FDA UDI
- Primary DI / UDI-DI
- 00819374022477 EUDAMEDFDA UDI
- Basic UDI-DI
- 081226101OPN058UV EUDAMED
- Direct Marketing DI
- 00819374022477 EUDAMED
- 510(k) Number
- K190590 FDA UDI
- FDA Product Code
- MQE FDA UDI
- EMDN Code
- Z12080202 OOCYTE ASPIRATION EQUIPMENT EUDAMED
- GMDN Term
- IVF oocyte aspiration needle, single-use FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA UDI
- Regulation Number
- 884.6100 FDA UDI
- Market of Registration
- Czechia 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
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
ACE Ovum Pickup Needle by Allwin Medical Devices, Inc. — 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 | 081226101OPN058UV | Class IIa | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIa | Pending data |
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Manufacturer
- Manufacturer
- Allwin Medical Devices, Inc
- EUDAMED SRN
- US-MF-000011349
- Authorised Representative
- CMC Medical Devices & Drugs SL ES-AR-000000293
Sources (3)
- EUDAMED e59395b2-434d-481a-a24e-a96c15b98775 61 fields · synced Jun 17, 2026
- FDA UDI c1f2dd21-37e9-4d11-9c98-69dc76b77034 36 fields · synced May 30, 2026
- EUDAMED 169da7f5-10d3-4eb8-a8f8-8ff3226fa3df 61 fields · synced Jun 11, 2026