Organization name

Hydas GmbH & Co. KG

SRN

DE-MF-000016598

Manufacturer status

Active

1 warning recorded — scroll inside the panel to see all entries.

• Contraindications / Not suitable In the case of the following medical conditions, it is only recommended to wear this article after consultation with your doctor: • Skin diseases/injuries in the affected part of the body, especially in inflammatory symptoms such as swelling, redness and overheating • Allergic reactions to the material • Sensory and movement disorders, e.g. in the case of diabetes • Open wounds or internal injuries • For small children or persons who can not be noticeable when the product sits uncomfortably Notes on safe use of the product Side effects affecting the whole organism are not yet known. Proper application is required. In case of improper use, product liability is excluded. • If the bandage is too tight or uncomfortable, remove it immediately! • The clothing sizes must be observed. • Used by the times by private users. • If your symptoms worsen or you notice unusual changes, consult your doctor immediately. Do not use: While sleeping

  OTHER

Primary placement in Germany; available across 29 countries total.

Trade name

Orthopädischer Bauch- und Rückenstützgürtel

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.

04004128025545

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.

4004128StuetzguertelRD

Reference / catalog number

1516.1.01

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

Durch äußeren Druck (Kompression) wird die Bauch-und Rückenmuskulatur aktiviert und unterstützt. Stützt die Wirbelsäule und fördert eine aufrechte Körperhaltung. Die Stützbandage gibt Halt und Sicherheit nach einer Operation zur Entlastung der Wunde. • Bandscheibenbeschwerden • Ischiasschmerzen • Hexenschuss • Überlastungsschmerz • Zur Rehabilitation nach Operationen Zum privaten Gebrauch

Additional information URL

No additional information URL provided by the manufacturer.

Clinical sizes

No clinical sizes registered for this device.

2 packaging levels registered — each level carries its own UDI-DI.

• 04004128025545× 1 unitBase unit
  • 04004128016796× 50 units
  • 04004128015546× 60 units

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

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

• M030499ELASTIC BANDAGES, SUPPORT AND COMPRESSION - OTHER

• Class I medical devices in EUDAMED

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