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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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PureSperm 100 — 1 UDI-DI variant, MDD (Nidacon International AB)

MD Atlas
Nidacon International AB

Data from EUDAMED, last updated May 30, 2026

PureSperm 100

B-07350025610047

1 UDI-DI variant

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

Legislation: MDD [Directive 93/42/EEC on medical devices]
Risk class: Class III
Manufacturer: Nidacon International AB

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Device characteristics

No device characteristics flagged

Legacy certificates

Certificate number: 241568-2017-CE-NOR-NA-PS
Type: refdata.legacy.mdd-certificate-type.ii-excluding-4
Notified body: DNV Product Assurance AS (2460)
Validity: Dec 17, 2022

Identity & classification

Basic UDI-DI: B-07350025610047
Device name: PureSperm 100
Device model: PS100-250
Issuing agency: EUDAMED
Legislation: MDD [Directive 93/42/EEC on medical devices]
Risk class: Class III
Version date: Jun 15, 2022

Manufacturer & authorised representative

Manufacturer

Name: Nidacon International AB
SRN: SE-MF-000001933
Country: Sweden
Email: contact@nidacon.com
Phone: +46 31 7030630

Variants by status

UDI-DI variants

1 UDI-DI variant

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Applied filters

basicUdiUlid01G5K3ZNX6KXZNQENXH64T04GD

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

PureSperm 10007350025610047