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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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SYSTEMS FOR METAPHYSEAL FRACTURES — 5 UDI-DI variants, MDR

MD Atlas
BIOPSYBELL SRL

Data from EUDAMED, last updated May 31, 2026

SYSTEMS FOR METAPHYSEAL FRACTURES

8033860OSTEOFT01CDE

5 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: BIOPSYBELL SRL

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Device characteristics

No device characteristics flagged

Legacy certificates

Certificate number: IT349638
Type: refdata.certificate-mdr-type.quality-assurance
Notified body: BUREAU VERITAS ITALIA S.P.A. (1370)
Validity: Feb 10, 2026 → Feb 9, 2030

Identity & classification

Basic UDI-DI: 8033860OSTEOFT01CDE
Device name: SYSTEMS FOR METAPHYSEAL FRACTURES
Issuing agency: GS1
Legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Risk class: Class IIa
Version date: Feb 5, 2026

Manufacturer & authorised representative

Manufacturer

Name: BIOPSYBELL SRL
SRN: IT-MF-000011601
Country: Italy
Email: support@biopsybell.it
Phone: +39053527850

Variants by status

UDI-DI variants

5 UDI-DI variants

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Applied filters

basicUdiUlid01KGQ3251HQNZ7QKDN52PHQ8D2

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

OPTYCAST08033860030865
OSTEOPLASTY ACCESS SYSTEM08033860030285
OSTEOPLASTY BALLOON08033860036034
OSTEOPLASTY BALLOON08033860039585
OSTEOPLASTY BALLOON08033860039387