← Back to catalogue

NICO Automated Preservation System

EUDAMEDFDA UDI

Class I (EU MDR)

Ref NN-1010

by NICO Corporation

Identity

Trade Name
NICO Automated Preservation System EUDAMEDFDA UDI
Generic Name
Neurosurgical procedure kit, non-medicated, single-use FDA UDI
Device Name
NICO Automated Preservation System EUDAMED
Preservation Pack - Clamshell FDA UDI
Model / Reference
NN-1010 EUDAMEDFDA UDI
Description
Preservation Pack - Clamshell FDA UDI

Identifiers

Primary DI / UDI-DI
00816744021108 EUDAMEDFDA UDI
Basic UDI-DI
081674402PP2FJ EUDAMED
FDA Product Code
FMH FDA UDI
EMDN Code
A090199 ORGAN COLLECTION CONTAINERS - OTHER EUDAMED
GMDN Term
Neurosurgical procedure kit, non-medicated, single-use FDA UDI

Classification

Device Class
Class I EUDAMEDFDA UDI
Regulation Number
864.3250 FDA UDI
Medical Purpose
Automated tissue collection and biological preservation, while in the operating suite EUDAMED
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

EUDAMEDFDA UDI

Single Use

No

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

Yes

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

No

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

No

FDA UDI

NICO Automated Preservation System by NICO Corporation — Class I — 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

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer
NICO Corporation
EUDAMED SRN
US-PR-000035011

Sources (2)

  • EUDAMED 4a695b7b-5d24-4a3c-a2ca-adc0fee1c7d7 61 fields · synced Jun 18, 2026
  • FDA UDI ece19738-f0c6-4ab5-9884-4da20c5e2198 34 fields · synced May 30, 2026