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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

MBT1164 — Class I MDR by Bolsaplast, S.L.

MD Atlas
Bolsaplast, S.L.

EUDAMED last updated this device on May 20, 2026

MBT1164

8437016867BOLSAPLASTT4

On the marketClass I

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: Bolsaplast, S.L.
UDI-DI code: 18437010679541
Reference / catalog number: MBT1164

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Manufacturer information

Organization name: Bolsaplast, S.L.
SRN: ES-MF-000000951
Manufacturer status: Active

Market distribution

Primary placement in Spain; available across 1 country total.

Country	On market since	Until
SpainPrimary placement	Jan 1, 2005	Still on market

Device identification

Trade name: not provided
UDI-DI code: 18437010679541
Basic UDI-DI: 8437016867BOLSAPLASTT4
Reference / catalog number: MBT1164
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: Paper/Film packaging for packing materials that must be submitted to a sterilization process
Additional information URL: https://www.bolsaplastmedical.com/ifu
Clinical sizes: No clinical sizes registered for this device.

EMDN nomenclature code(s)

S01010201FLAT STERILISATION POUCHES, TYVEK/PLASTIC FILM

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

MBF12078437016867BOLSAPLASTT4On the market MBO10108437016867BOLSAPLASTT4On the market MBO10298437016867BOLSAPLASTT4On the market MBT11638437016867BOLSAPLASTT4On the market MBT11628437016867BOLSAPLASTT4On 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.