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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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Organization name
UDI-DI code
Reference / catalog number

Sterimed Fix — Class I MDR by Sopharma AD

MD Atlas
Sopharma AD

EUDAMED last updated this device on Aug 10, 2022

Sterimed Fix

3800010632001593

On the marketClass I

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: Sopharma AD
UDI-DI code: 03800728495136
Reference / catalog number: 32001000-0084

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Manufacturer information

Organization name: Sopharma AD
SRN: BG-MF-000019983
Manufacturer status: Active

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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.

Critical warnings

3 warnings recorded — scroll inside the panel to see all entries.

CW007
The dressing shall not be used if the integrity of the package has been compromised.
CW009
The product is for single use.
CW011
1. The product does not stretch when applying. / 2. The wound should be inspected for signs of infection.

Market distribution

Primary placement in Bulgaria; available across 1 country total.

Country	On market since	Until
BulgariaPrimary placement	May 21, 2021	Oct 31, 2023

Device identification

Trade name: Sterimed Fix
UDI-DI code: 03800728495136
Basic UDI-DI: 3800010632001593
Reference / catalog number: 32001000-0084
Issuing entity: GS1

Classification

Risk category: Class I
Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Status: On the market

Device details

Quantity: 1
Additional product description: Sterile wound dressing (Breathable / Self Adhesive) - 10 cm / 25 cm;
Additional information URL: No additional information URL provided by the manufacturer.
Clinical sizes: No clinical sizes registered for this device.

EMDN nomenclature code(s)

M04010101NON-WOVEN ADHESIVE DRESSINGS, WITH ABSORBENT PAD

Compliance flags

Safety

Sterile

Single use

Contains latex

Reprocessed single-use

Direct marking

Substances

CMR substance

Endocrine disruptor

Regulatory

Annex XVI applicable

Sterilization

Lifecycle

New device

UDI-PI traceability

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Manufacturing date
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Software identification