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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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Sanplast — 22 UDI-DI variants, MDR (Sopharma AD)

MD Atlas
Sopharma AD

Data from EUDAMED, last updated May 23, 2026

Sanplast

380001063200318Z

22 UDI-DI variants

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

Legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Risk class: Class I
Manufacturer: Sopharma AD

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Device characteristics

No device characteristics flagged

Clinical investigations

Registered: No

Investigation number: Sanplast Classic - Skin irritation test (intradermal reactivity) – Report Reg. SDWH -2010-20504
Registered: No
Countries: China

Investigation number: Sanplast Classic - Citotoxicity assey - Report Reg. SDWH -2010-20195
Registered: No
Countries: China

Registered: No

Registered: No

Registered: No

Investigation number: Sanplast Film - Skin irritation test Report Reg. SDFY-2007-2254
Registered: No
Countries: China

Registered: No

Investigation number: Sanplast Silk plus - Skin irritation test – Report Reg. SDWH-M201401625
Registered: No
Countries: China

Investigation number: Sanplast Silk Plus - Citotoxicity assey - Report Reg. SDWH-M201401623
Registered: No
Countries: China

Investigation number: Sanplast Silk Plus - Intracutaneous – Report Reg. SDWH-M201401624
Registered: No
Countries: China

Registered: No

Registered: No

Registered: No

Identity & classification

Basic UDI-DI: 380001063200318Z
Device name: Sanplast
Issuing agency: GS1
Legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Risk class: Class I
Version date: Aug 11, 2022

Manufacturer & authorised representative

Manufacturer

Name: Sopharma AD
SRN: BG-MF-000019983
Country: Bulgaria
Email: mail@sopharma.bg
Phone: +35980020222

Variants by status

UDI-DI variants

22 UDI-DI variants

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Applied filters

basicUdiUlid01GA61QDH8RNSB62EBYBQHQA1P

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

Citofix03800728497871
Sanplast Citofilm03800728496904
Sanplast Citofilm03800728496881
Sanplast Citofilm03800728496911
Sanplast Citofix03800728497758
Sanplast Citofix03800728497796
Sanplast Citofix03800728497765
Sanplast Citofix03800728497772
Sanplast Citofix03800728497819
Sanplast Citofix03800728497710
Sanplast Citofix03800728497956
Sanplast Classic03800728496447
Sanplast Classic03800728496461
Sanplast Classic03800728496454
Sanplast Classic 10 pcs.03800010647229
Sanplast Classic Extra03800728496126
Sanplast Classic Extra03800728496119
Sanplast Delicate03800728497635
Sanplast Delicate03800728497642
Sanplast Film03800728496355
Sanplast Silk03800728496850
Sanplast Silk03800728496867