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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

Butler Grindcare Gelpad — Class I MDD by Sunstar Europe SA

MD Atlas
Sunstar Europe SA

EUDAMED last updated this device on Jun 28, 2022

Butler Grindcare Gelpad

B-17630019900130

On the marketClass I

Applicable legislation: MDD [Directive 93/42/EEC on medical devices]
Organization name: Sunstar Europe SA
UDI-DI code: 17630019900130
Reference / catalog number: 99GC402G

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Manufacturer information

Organization name: Sunstar Europe SA
SRN: CH-MF-000023162
Manufacturer status: Active

Related devices

BUTLER GRINDCARE DEVICEB-17630019900161On the market BUTLER PALPETERB-17630019900192On the market GUM AFTA CLEAR GELB-17630019900284On the market GUM AFTACLEAR GELB-17630019900314On the market GUM AFTACLEAR GELB-17630019900253On the market

Market distribution

Primary placement in Germany; available across 1 country total.

Placed on the market in Germany; per-country availability dates not published.

Device identification

Trade name: Butler Grindcare Gelpad
UDI-DI code: 17630019900130
Basic UDI-DI: B-17630019900130
Reference / catalog number: 99GC402G
Issuing entity: GS1

Classification

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

Device details

Quantity: 1
Additional product description: —
Additional information URL: No additional information URL provided by the manufacturer.
Clinical sizes: No clinical sizes registered for this device.

EMDN nomenclature code(s)

Z12062485BIOFEEDBACK INSTRUMENTS - CONSUMABLES

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

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.