Identity
- Trade Name
- Acquire™ EUDAMEDAcquire™ S FDA UDI
- Generic Name
- General-purpose endoscopic needle, single-use FDA UDI
- Device Name
- Acquire S EUDAMEDEndoscopic Ultrasound Fine Needle Biopsy (FNB) Device FDA UDI
- Model / Reference
- M00555640 EUDAMEDFDA UDI
- Description
- Endoscopic Ultrasound Fine Needle Biopsy (FNB) Device FDA UDI
Identifiers
- Catalog Number
- M00555640 FDA UDI
- Primary DI / UDI-DI
- 00191506030742 EUDAMEDFDA UDI
- Basic UDI-DI
- 01915060000000000000546NH EUDAMED
- FDA Product Code
- ODG FDA UDI
- EMDN Code
- A010299 BIOPSY NEEDLES AND KITS - OTHER EUDAMED
- GMDN Term
- General-purpose endoscopic needle, single-use FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA UDI
- Regulation Number
- 876.1500 FDA UDI
- Market of Registration
- Netherlands 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
Yes
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
No
FDA UDI
Dimensions & Sizes
- Size
- Needle Gauge — 22 Gauge FDA UDI
Category: Needle guide, single-use
Acquire™ by Boston Scientific — Class IIa — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Needle guide, single-use.
- Sterile Disposable Endocavity Needle Guide Kit — PROTEK MEDICAL PRODUCTS, INC. · Class II
- Sterile transrectal needle guide with sheath — Exact Imaging · Class II
- Sterile Disposable Endocavity Needle Guide — PROTEK MEDICAL PRODUCTS, INC. · Class II
- Coaxial needle — Möller Medical GmbH · Class II
- Biopsy Starter Kit — CIVCO MEDICAL INSTRUMENTS CO., INC. · Class II
- Coaxial needle — Möller Medical GmbH · Class II
- Needle Guide — CIVCO MEDICAL INSTRUMENTS CO., INC. · Class II
- InnoFine — JingFang Precision Medical Device(Shenzhen) Co., Ltd. · Class II
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 | 01915060000000000000546NH | Class IIa | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIa | Pending data |
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Manufacturer
- Manufacturer
- Boston Scientific Corporation
- EUDAMED SRN
- US-MF-000004702
- Authorised Representative
- Boston Scientific Limited IE-AR-000003840
Sources (2)
- EUDAMED 89a69fbc-35ec-46ba-9462-541556867766 61 fields · synced May 30, 2026
- FDA UDI bdeea101-f4f2-4a6f-a8db-b5e95213ef1a 35 fields · synced May 30, 2026