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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

BTX05100 — 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

BTX05100

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: 05944792000082
Reference / catalog number: BTX05100

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Manufacturer information

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

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, 2059

Device identification

Trade name: not provided
UDI-DI code: 05944792000082
Basic UDI-DI: 5944792NSTERGAUZEROLBDGLW
Reference / catalog number: BTX05100
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: 5cm/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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