Organization name

Guilin HBM Health Protections, Inc.

SRN

CN-MF-000033439

Manufacturer status

Active

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

• Product contains natural rubber latex which may cause allergic reactions including anaphylactic responses. Product for single use. Do not reuse. Do not use if the product is damaged. Do not use after the expiry date stated on the package label.

  OTHER

Primary placement in Poland; available across 26 countries total.

Trade name

dermagel plus underglove

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.

06931923800474

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.

697178707SGNRUF

Reference / catalog number

RC10065065_2937

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 IIa

Applicable legislation

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

Status

On the market

Quantity

1

Additional product description

6.5

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.

• 06931923800474× 1 unitBase unit
  • 16931923800471× 50 units
    • 26931923800478× 8 units

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

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

• T01010102NON-POWDERED LATEX SURGICAL GLOVES

• Class IIa medical devices in EUDAMED

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

Certificate health across this manufacturer's portfolio.