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CoreTainer

EUDAMEDFDA UDI

Class A (EU MDR)

Ref 301

by Beekley Corporation

Identity

Trade Name
CoreTainer FDA UDI
Generic Name
General specimen container IVD, no additive/medium FDA UDI
Device Name
CoreTainer EUDAMED
Stereotactic Core Biopsy Image and Transport System FDA UDI
Model / Reference
301 EUDAMEDFDA UDI
Description
Stereotactic Core Biopsy Image and Transport System FDA UDI

Identifiers

Primary DI / UDI-DI
00815137021145 EUDAMEDFDA UDI
Basic UDI-DI
00815137021145BA EUDAMED
Unit of Use DI
10815137021142 EUDAMED
FDA Product Code
NNI FDA UDI
EMDN Code
W05020199 SAMPLES TRANSPORT, CONTAINERS - OTHER EUDAMED
GMDN Term
General specimen container IVD, no additive/medium FDA UDI

Classification

Device Class
Class A EUDAMED
Class I FDA UDI
Regulation Number
864.3250 FDA UDI
Market of Registration
Netherlands EUDAMED
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

EUDAMEDFDA UDI

Single Use

Yes

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Human Tissues

No

EUDAMED

Animal Tissues

No

EUDAMED

Microbial Substances

No

EUDAMED

Reagent

No

EUDAMED

Self Testing

No

EUDAMED

Near-Patient Testing

No

EUDAMED

Professional Testing

No

EUDAMED

Companion Diagnostics

No

EUDAMED

Surgical Instrument

No

EUDAMED

New Device

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

No

FDA UDI

Manufacturing Date

No

FDA UDI

The CoreTainer is a cutting-edge medical device that enables precise and accurate measurement of biological fluids, providing valuable insights into patient health. Our device combines advanced technology with rigorous testing to ensure its reliability and effectiveness.

Authorization Coverage (2 countries)

Regulatory Authorizations

European Union Active

CE/IVDR

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Beekley Corporation
EUDAMED SRN
US-MF-000007055
Authorised Representative
Emergo Europe B.V. NL-AR-000000116

Sources (2)

  • EUDAMED f15b9e52-f1a1-41d0-b360-27f67781fbae 61 fields · synced Jul 8, 2026
  • FDA UDI 4c704b27-54cb-4816-a4a6-e8426206328a 33 fields · synced May 29, 2026