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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

HenroCup® Institution — Class I MDR by Henrotek A/S

MD Atlas
Henrotek A/S

EUDAMED last updated this device on May 8, 2024

HenroCup® Institution

57048312BW

On the marketClass I

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: Henrotek A/S
UDI-DI code: 05704831128852
Reference / catalog number: Ref no. 12885

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View device family (Basic UDI)

Manufacturer information

Organization name: Henrotek A/S
SRN: DK-MF-000029313
Manufacturer status: Active

Critical warnings

No critical warnings reported for this device.

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Market distribution

Primary placement in Belgium; available across 1 country total.

Placed on the market in Belgium; per-country availability dates not published.

Device identification

Trade name: HenroCup® Institution
UDI-DI code: 05704831128852
Basic UDI-DI: 57048312BW
Reference / catalog number: Ref no. 12885
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: HenroCup® is designed and intended for beverage and food only. HenroCup® has been developed by Danish occupational therapists to ensure a high-quality cup for people that experience loss of strength and coordination. HenroCup® is not BPA Free and should not be used by children under the age of 3 years old. HenroCup® is designed with 2 wide handles to give a firm grip, the shape of the cup and handles ensures that you can drink without bending the neck. The bottom of the cup is wide to help it stand firm on the table and reduces spillage.
Additional information URL: https://www.henrotek.com/
Clinical sizes: 139 gr
9 cm
15 cm

UDI-PI traceability

Batch number
Expiration date
Manufacturing date
Serial number
Software identification

UDI-DI DataMatrix

Encoded

(01)05704831128852

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UDI-PI DataMatrix

The compliance carrier: encodes the device identifier plus the production identifiers (lot, serial, dates) registered for this device.

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EMDN nomenclature code(s)

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

Y0999PERSONAL CARE AIDS - OTHER

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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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.