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Organization name
UDI-DI code
Reference / catalog number

# 35.00 — IVDD — General IVDD by GONOTEC Gesellschaft…

MD Atlas
GONOTEC Gesellschaft für Meß- und Regeltechnik mbH

EUDAMED last updated this device on Jun 7, 2023

# 35.00

B-04260341780702

On the marketIVDD — General

Applicable legislation: IVDD [Directive 98/79/EC on in vitro diagnostic medical devices]
Organization name: GONOTEC Gesellschaft für Meß- und Regeltechnik mbH
UDI-DI code: 04260341780702
Reference / catalog number: # 35.00

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Manufacturer information

Organization name: GONOTEC Gesellschaft für Meß- und Regeltechnik mbH
SRN: DE-MF-000006548
Manufacturer status: Active

Critical warnings

1 warning recorded — scroll inside the panel to see all entries.

CW018
User Guide

Market distribution

Primary placement in Germany; available across 1 country total.

Placed on the market in Germany; per-country availability dates not published.

Device identification

Trade name: not provided
UDI-DI code: 04260341780702
Basic UDI-DI: B-04260341780702
Reference / catalog number: # 35.00
Issuing entity: GS1

Classification

Risk category: IVDD — General
Applicable legislation: IVDD [Directive 98/79/EC on in vitro diagnostic medical devices]
Status: On the market

Device details

Quantity: 1
Additional product description: Fully automatic freezing point osmometer with up to 20 measurements in one batch with 50µl sample volume and built-in printer
Additional information URL: No additional information URL provided by the manufacturer.
Clinical sizes: No clinical sizes registered for this device.

EMDN nomenclature code(s)

W02079017OSMOMETERS

Compliance flags

Safety

Sterile

Single use

Direct marking

Regulatory

Sterilization

Lifecycle

New device

UDI-PI traceability

Batch number
Expiration date
Manufacturing date
Serial number
Software identification

Related devices

# 32.02000B-04260341780672On the market # 32.00000B-04260341780658On the market # 32.12000B-04260341780689On the market # 32.BB-04260341780696On the market # 32.10000B-04260341780665On the market

Certificates

No certificates registered for this manufacturer.

No certificate references this Basic UDI-DI, because: • It does not require a certificate, or • It only requires a certificate without a Basic UDI-DI reference (e.g. a QMS certificate), or • The required certificate(s) referencing this Basic UDI-DI have not been registered yet.