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ACE Ovum Pickup Needle

EUDAMEDFDA UDIFDA 510(k)

Class IIa (EU MDR)

Ref A-OVM-SL17/35-FLModel 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 Needle510(k) K190590Ref A-OVM-SL17/35Ref A-OVM-SL16/35Ref A-OVM-SL18/35-MRef A-OVM-SL18/35Ref A-OVM-SL17/35-M

by Allwin Medical Devices, Inc

Identity

Trade Name
ACE Ovum Pickup Needle EUDAMED
ACE-M FDA UDI
ACE-FL FDA UDI
ACE FDA UDI
ACE Single Lumen Ovum Pickup Needle FDA UDI
Generic Name
IVF oocyte aspiration needle, single-use FDA UDI
Device Name
OVUM PICKUP NEEDLE EUDAMED
ACE-M Manual Single Lumen Ovum Pickup Needle 18G, 35 cm FDA UDI
ACE Single Lumen Ovum Pick-up Needle 17G 35cm with Flushing Line FDA UDI
ACE-M Manual Single Lumen Ovum Pickup Needle 17G, 35 cm FDA UDI
ACE Single Lumen Ovum Pickup Needle 16G, 35cm FDA UDI
Ace Single Lumen Ovum Pickup Needle (17G,35cm) 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 EUDAMED
A-OVM-SL17/35-FL EUDAMED
A-OVM-SL17/35 EUDAMEDFDA UDI
A-OVM-SL16/35 EUDAMED
A-OVM-SL18/35-M EUDAMED
A-OVM-SL18/35 EUDAMED
A-OVM-SL17/35-M EUDAMED
ACE-M Manual Single Lumen Ovum Pickup Needle 18G, 35 cm FDA UDI
ACE Single Lumen Ovum Pick-up Needle 17G 35cm with Flushing Line FDA UDI
ACE-M Manual Single Lumen Ovum Pickup Needle 17G, 35 cm FDA UDI
ACE Single Lumen Ovum Pickup Needle 16G, 35cm FDA UDI
Description
ACE-M Manual Single Lumen Ovum Pickup Needle 18G, 35 cm FDA UDI
ACE Single Lumen Ovum Pick-up Needle 17G 35cm with Flushing Line FDA UDI
ACE-M Manual Single Lumen Ovum Pickup Needle 17G, 35 cm FDA UDI
ACE Single Lumen Ovum Pickup Needle 16G, 35cm FDA UDI
Ace Single Lumen Ovum Pickup Needle (17G,35cm) FDA UDI

Identifiers

Catalog Number
A-OVM-SL 18/35-M FDA UDI
A-OVM-SL-FL 17/35 FDA UDI
A-OVM-SL17-35-M FDA UDI
A-OVM-SL 16/35 FDA UDI
Primary DI / UDI-DI
00819374020589 EUDAMEDFDA UDI
00812261016870 EUDAMEDFDA UDI
00819374022460 EUDAMEDFDA UDI
00819374022484 EUDAMEDFDA UDI
00819374022545 EUDAMED
00819374021906 EUDAMEDFDA UDI
Basic UDI-DI
081226101OPN058UV EUDAMED
Direct Marketing DI
00819374020589 EUDAMED
00812261016870 EUDAMED
00819374022460 EUDAMED
00819374022484 EUDAMED
00819374022545 EUDAMED
00819374021906 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 EUDAMED
Class II FDA UDI
Regulation Number
884.6100 FDA UDI
Market of Registration
Türkiye EUDAMED
Czechia EUDAMED
Poland 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

ACE Ovum Pickup Needle by Allwin Medical Devices, Inc. — 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

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Manufacturer

Manufacturer
Allwin Medical Devices, Inc
EUDAMED SRN
US-MF-000011349
FDA Applicant
Allwin Medical Devices, Inc.
Authorised Representative
CMC Medical Devices & Drugs SL ES-AR-000000293

Sources (18)

  • EUDAMED c984d029-ce87-4697-bc6d-ba8f86b5140e 85 fields · synced Sep 17, 2026
  • EUDAMED bccb19be-c0b7-40b8-b901-eedc2e40e163 61 fields · synced May 17, 2026
  • EUDAMED ccc1aa33-ea44-44f6-bf68-f08ec4e1da58 61 fields · synced May 18, 2026
  • EUDAMED f2bc1558-5335-48ad-b0f0-ec442595de6b 61 fields · synced May 18, 2026
  • EUDAMED cad7cdbf-1259-4f00-91d8-aa950ecb06b0 61 fields · synced May 19, 2026
  • EUDAMED 47e456d3-d174-4ffc-8f78-596cee9f071a 61 fields · synced May 19, 2026
  • FDA UDI 72a07cc5-294a-4c6b-b947-96c7f3b830be 36 fields · synced May 29, 2026
  • FDA UDI e52f4307-4cc0-4ffc-8de6-29c5b5e48665 36 fields · synced May 30, 2026
  • FDA UDI 093f1760-9071-4005-bde8-610780b6677e 36 fields · synced May 30, 2026
  • FDA UDI b9beada1-f99a-4608-8685-917c2569bb02 36 fields · synced May 30, 2026
  • FDA UDI 54fb5855-e17d-402c-81fb-6c0dcb58a5bd 35 fields · synced May 30, 2026
  • EUDAMED 580af540-1926-479e-8bd1-127e3ef7811d 61 fields · synced Jul 10, 2026
  • EUDAMED 8579e266-2fb3-409b-ab03-de3aa8a2a839 61 fields · synced Jul 11, 2026
  • EUDAMED 097bfc2f-d0dc-4b78-8ea0-47f2a5e881f1 61 fields · synced Jul 13, 2026
  • EUDAMED 4fe1d41f-7d21-4126-b661-fd4f9ab3de86 61 fields · synced Jul 22, 2026
  • EUDAMED 43d27458-0c08-429c-bd7a-b784e0c27fbc 61 fields · synced Aug 2, 2026
  • EUDAMED 374dd8ea-5579-40fa-9a75-a02071ad1b18 61 fields · synced Sep 17, 2026
  • FDA 510(k) K190590 1 fields · synced May 18, 2026