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Organization name
UDI-DI code
Reference / catalog number

Gauze Compresses Non Sterile — Class IIa MDR by Sopharma AD

MD Atlas
Sopharma AD

EUDAMED last updated this device on May 20, 2022

Gauze Compresses Non Sterile

380001063200128V

On the marketClass IIa

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: Sopharma AD
UDI-DI code: 03800728710390
Reference / catalog number: 32001000-0068

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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.

Market distribution

Primary placement in Bulgaria; available across 1 country total.

Country	On market since	Until
BulgariaPrimary placement	May 21, 2021	Jul 12, 2024

Device identification

Trade name: Gauze Compresses Non Sterile
UDI-DI code: 03800728710390
Basic UDI-DI: 380001063200128V
Reference / catalog number: 32001000-0068
Issuing entity: GS1

Classification

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

Device details

Quantity: 100
Additional product description: Gauze Compresses Non Sterile 10 cm/ 10 cm x 16 ply
Additional information URL: No additional information URL provided by the manufacturer.
Clinical sizes: No clinical sizes registered for this device.

EMDN nomenclature code(s)

M0201020102COTTON GAUZES, FOLDED, WITHOUT X-RAY DETECTABLE THREAD, NON-STERILE

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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