Halbrolle Skinfoam

Organization name

POLYFORM-Kunststofftechnik GmbH &Co. Betriebs KG

SRN

DE-MF-000005057

Manufacturer status

Active

No certificate specifically references this device's Basic UDI-DI.

Primary placement in Germany; available across 9 countries total.

Trade name

Halbrolle Skinfoam

UDI-DI code

Primary DI

The Primary DI is the main UDI-DI a manufacturer designates as the principal identifier for a device in EUDAMED.

04001363010183

Basic UDI-DI

Basic UDI-DI

The Basic UDI-DI is the main identifier that groups together all device variants of the same model — the regulatory "family" key.

4001363PFLH001B7

Reference / catalog number

164534

Issuing entity

UDI issuing entities

Issuing entities are the organisations the European Commission has designated to assign Unique Device Identifiers under the EU's UDI system.

GS1

Risk category

MDR risk classes

MDR risk classes rank medical devices from lowest risk (Class I) to highest (Class III), which determines how much regulatory scrutiny they face.

Class I

Applicable legislation

MDR [Regulation (EU) 2017/745 on medical devices]

Status

On the market

Quantity

1

Additional product description

Halbrolle Skinfoam blau 115/75x155 mm

Additional information URL

https://www.polyform.de/

Clinical sizes

No clinical sizes registered for this device.

• Batch number
• Expiration date
• Manufacturing date
• Serial number
• Software identification

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

• V080302PATIENT POSITIONING MEDICAL CUSHIONS

• Class I medical devices in EUDAMED