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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

MBT1163 — Class I MDR by Bolsaplast, S.L.

MD Atlas
Bolsaplast, S.L.

EUDAMED last updated this device on May 20, 2026

MBT1163

8437016867BOLSAPLASTT4

On the marketClass I

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: Bolsaplast, S.L.
UDI-DI code: 18437010679534
Reference / catalog number: MBT1163

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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: 18437010679534
Basic UDI-DI: 8437016867BOLSAPLASTT4
Reference / catalog number: MBT1163
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

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.

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