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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

BTX10100 — Class I MDR by Bandtex Grup S.R.L.

MD Atlas
Bandtex Grup S.R.L.

EUDAMED last updated this device on Apr 21, 2026

BTX10100

5944792NSTERGAUZEROLBDGLW

On the marketClass I

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: Bandtex Grup S.R.L.
UDI-DI code: 05944792000037
Reference / catalog number: BTX10100

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Manufacturer information

Organization name: Bandtex Grup S.R.L.
SRN: RO-MF-000004081
Manufacturer status: Active

Related devices

BTX1010081005944792NSTERGAUZESWABS1MROn the market BTX40401005944792NSTERGAUZESWABS1MROn the market BTX051005944792NSTERGAUZEROLBDGLWOn the market BTX050505944792NSTERGAUZEROLBDGLWOn the market BTX201005944792NSTERGAUZEROLBDGLWOn 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.

Critical warnings

No critical warnings reported for this device.

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Market distribution

Primary placement in Romania; available across 1 country total.

Country	On market since	Until
RomaniaPrimary placement	Jan 1, 2014	Jan 1, 2050

Device identification

Trade name: not provided
UDI-DI code: 05944792000037
Basic UDI-DI: 5944792NSTERGAUZEROLBDGLW
Reference / catalog number: BTX10100
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: 10cm/10M non-sterile gauze bandage made of cotton, single use device intended for: fixation and retention of primary sterile wound dressings or other medical devices; secondary wound protection with absorption of excess blood or exudate; application of compression; protection against abrasion and mechanical impact; support and immobilisation of body parts. Not intended for direct contact with open wounds.
Additional information URL: https://www.sanrotex.ro/
Clinical sizes: No clinical sizes registered for this device.

UDI-PI traceability

Batch number
Expiration date
Manufacturing date
Serial number
Software identification

EMDN nomenclature code(s)

European Medical Device Nomenclature — the EU product classification assigned to this device.

M030101HYDROPHILIC GAUZE BANDAGES

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

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