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Organization name
UDI-DI code
Reference / catalog number

2042-HRM-XL — Class I MDR by Puhla Oy

MD Atlas
Puhla Oy

EUDAMED last updated this device on Oct 23, 2024

2042-HRM-XL

643007415phlwearhygKP

On the marketClass I

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: Puhla Oy
UDI-DI code: 06430074151164
Reference / catalog number: 2042-HRM-XL

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Manufacturer information

Organization name: Puhla Oy
SRN: FI-MF-000042691
Manufacturer status: Inactive

Related devices

2041-HRM-XL643007415phlwearhygKPOn the market 2041-HRM-M643007415phlwearhygKPOn the market 2041-HRM-XS643007415phlwearhygKPOn the market 2041-HRM-L643007415phlwearhygKPOn the market 2041-HRM-S643007415phlwearhygKPOn 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.

Market distribution

Primary placement in Finland; available across 1 country total.

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

Device identification

Trade name: not provided
UDI-DI code: 06430074151164
Basic UDI-DI: 643007415phlwearhygKP
Reference / catalog number: 2042-HRM-XL
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: Hygieniahaalari pitkällä polveen asti avautuvalla vetoketjulla, 2/3 hihoilla, harmaa, koko XL
Additional information URL: https://www.puhla.com/tuote-osasto/hoivavaatteet/hygieniahaalarit/
Clinical sizes: No clinical sizes registered for this device.

EMDN nomenclature code(s)

T0299PROTECTION DRAPES AND GARMENTS - 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

UDI-PI traceability

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