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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

SBSA — Class III MDD by Grade Medical s.r.o.

MD Atlas
Grade Medical s.r.o.

EUDAMED last updated this device on Mar 20, 2023

SBSA

B-859417794SBSATDYC

On the marketClass III

Applicable legislation: MDD [Directive 93/42/EEC on medical devices]
Organization name: Grade Medical s.r.o.
UDI-DI code: D-859417794SBSATDYC
Reference / catalog number: SBSA

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Manufacturer information

Organization name: Grade Medical s.r.o.
SRN: CZ-MF-000004221
Manufacturer status: Inactive

Market distribution

Primary placement in Czechia; available across 1 country total.

Country	On market since	Until
CzechiaPrimary placement	Mar 27, 2018	Mar 26, 2023

Device identification

Trade name: not provided
UDI-DI code: D-859417794SBSATDYC
Basic UDI-DI: B-859417794SBSATDYC
Reference / catalog number: SBSA
Issuing entity: EUDAMED

Classification

Risk category: Class III
Applicable legislation: MDD [Directive 93/42/EEC on medical devices]
Status: On the market

Device details

Quantity: 1
Additional product description: Hypoallergenic antibacterial surgical dressing StopBac STERILE Aquastop.
Additional information URL: No additional information URL provided by the manufacturer.
Clinical sizes: No clinical sizes registered for this device.

EMDN nomenclature code(s)

M050199SURGICAL PLASTERS - OTHER

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

Batch number
Expiration date
Manufacturing date
Serial number
Software identification

Related devices

SBSB-859417794SBSNU7ZQOn the market StopBac STERILE CompressB-859417794SBSCTHYWOn the market

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.