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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

tipstim glove — Class I MDR by BOSANA Medizintechnik…

MD Atlas
BOSANA Medizintechnik GmbH

EUDAMED last updated this device on Mar 5, 2025

tipstim glove

PP01940TIPGLO61

On the marketClass I

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: BOSANA Medizintechnik GmbH
UDI-DI code: 1301940BOS0010193
Reference / catalog number: BOSAN/0010

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Manufacturer information

Organization name: BOSANA Medizintechnik GmbH
SRN: DE-MF-000006978
Manufacturer status: Active

Critical warnings

1 warning recorded — scroll inside the panel to see all entries.

CW010
EUDAMED did not publish a description for this code.

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: tipstim glove
UDI-DI code: 1301940BOS0010193
Basic UDI-DI: PP01940TIPGLO61
Reference / catalog number: BOSAN/0010
Issuing entity: IFA

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: - Usability: for 100 applications 60 minutes each - Don‘t turn inside out - Single Patient - multiple use material: 85 % Polyamid, 15 % Elasthan inlay: 100 % Polyester electrode: 94 % Polyamid, 6 % Dorlastan pad: 100 % Polyester
Additional information URL: https://www.tipstim.com/
Clinical sizes: No clinical sizes registered for this device.

EMDN nomenclature code(s)

Z12062780FUNCTIONAL ELECTRICAL STIMULATION SYSTEMS - HARDWARE ACCESSORIES

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

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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.