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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

TT002 — Class I MDR by PROMECON GmbH

MD Atlas
PROMECON GmbH

EUDAMED last updated this device on Dec 15, 2025

TT002

426043471CarrierBag7W

On the marketClass I

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: PROMECON GmbH
UDI-DI code: 04260579678826
Reference / catalog number: TT002

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Manufacturer information

Organization name: PROMECON GmbH
SRN: DE-MF-000015290
Manufacturer status: Active

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: not provided
UDI-DI code: 04260579678826
Basic UDI-DI: 426043471CarrierBag7W
Reference / catalog number: TT002
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: Nylon waist bag for single use infusion pumps; size: 30cm x 10cm x 6cm: i.a. fits CareVis® pumps up to 275 ml (size I, L): CareVis Bag is an accessory that facilitates the transportation and ambulatory use of single-use infusion pumps. It features an adjustable strap and buckle, allowing patients of various sizes and statures to wear it comfortably around the waist or shoulder. The bag is easy to clean and can be disinfected with standard disinfectants and alcohol.
Additional information URL: No additional information URL provided by the manufacturer.
Clinical sizes: No clinical sizes registered for this device.

EMDN nomenclature code(s)

A0580MECHANICAL INFUSION SYSTEMS, SINGLE-USE - 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

TT001426043471CarrierBag7WOn the market TT003426043471CarrierBag7WOn 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.