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Our data is continuously updated and sourced from EUDAMED, the European database for medical devices and in vitro diagnostics.

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Ampolla FASTERJET (NEB101) — 1 UDI-DI variant, MDD

MD Atlas
3A HEALTH CARE S.r.l.

Data from EUDAMED, last updated May 30, 2026

Ampolla FASTERJET (NEB101)

B-08033717011764

1 UDI-DI variant

MDD [Directive 93/42/EEC on medical devices]Class IIa

Legislation: MDD [Directive 93/42/EEC on medical devices]
Risk class: Class IIa
Manufacturer: 3A HEALTH CARE S.r.l.

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Device characteristics

Administers medicine

Legacy certificates

Certificate number: 1951
Type: refdata.legacy.mdd-certificate-type.ii-excluding-4
Notified body: IMQ ISTITUTO ITALIANO DEL MARCHIO DI QUALITÀ S.P.A. (0051)
Validity: May 26, 2024

Identity & classification

Basic UDI-DI: B-08033717011764
Device name: —
Device model: Ampolla FASTERJET (NEB101)
Issuing agency: EUDAMED
Legislation: MDD [Directive 93/42/EEC on medical devices]
Risk class: Class IIa
Version date: Mar 20, 2026

Manufacturer & authorised representative

Manufacturer

Name: 3A HEALTH CARE S.r.l.
SRN: IT-MF-000009298
Country: Italy
Email: info_omronhealthcare@omron.com

Variants by status

UDI-DI variants

1 UDI-DI variant

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basicUdiUlid01KM5S09SW3ZGXTQYR3SDP49PY

Format

Summary

29 columns included

Trade name
Basic UDI-DI
UDI-DI code
Risk category
Applicable legislation
Status
Organization name
SRN
Reference / catalog number
Additional product description
Intended medical purpose
Placed on the market (country)
Market info update date
Sterile
Single use
Contains latex
Reprocessed single-use
Direct marking
CMR substance
Endocrine disruptor
Annex XVI applicable
Sterilization
OEM applicable
EMDN codes
Last updated
Basic UDI-DI device name
Basic UDI-DI device model
Basic UDI-DI implantable
Basic UDI-DI reagent

NEB10108033717011764