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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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Spirotome — 26 UDI-DI variants, MDR (Bioncise NV)

MD Atlas
Bioncise NV

Data from EUDAMED, last updated May 23, 2026

Spirotome

5407005001035PU

26 UDI-DI variants

MDR [Regulation (EU) 2017/745 on medical devices]Class IIa

Legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Risk class: Class IIa
Manufacturer: Bioncise NV

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Device characteristics

No device characteristics flagged

Identity & classification

Basic UDI-DI: 5407005001035PU
Device name: Spirotome
Device model: SS‐08‐10
Issuing agency: GS1
Legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Risk class: Class IIa
Version date: Mar 13, 2026

Manufacturer & authorised representative

Manufacturer

Name: Bioncise NV
SRN: BE-MF-000000875
Country: Belgium
Email: jaak.janssens@bioncise.com
Phone: +3211271557

Variants by status

UDI-DI variants

26 UDI-DI variants

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Applied filters

basicUdiUlid01KKKMZ80CT3HV2C7B81ZQSNAT

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

Spirotome05407005001189
Spirotome Bone05407005001233
Spirotome Bone05407005001240
Spirotome Cervicore05407005001172
Spirotome Endo05407005001226
Spirotome Endo05407005001219
Spirotome Endo05407005001202
Spirotome Endo05407005001196
Spirotome SS‐08-MR05407005001158
Spirotome SS‐08‐0605407005001059
Spirotome SS‐08‐0805407005001042
Spirotome SS‐08‐1005407005001035
Spirotome SS‐08‐1505407005001028
Spirotome SS‐08‐2005407005001011
Spirotome SS‐08‐MR05407005001165
Spirotome SS‐10‐0605407005001103
Spirotome SS‐10‐0805407005001097
Spirotome SS‐10‐1005407005001080
Spirotome SS‐10‐1505407005001073
Spirotome SS‐10‐2005407005001066
Spirotome SS‐14-0605407005001141
Spirotome SS‐14‐0805407005001134
Spirotome SS‐14‐1005407005001127
Spirotome SS‐14‐1505407005001110
Spirotome SS‐16-FL05407005001301

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