Organization name

Pharmaplast

SRN

EG-MF-000004501

Manufacturer status

Active

4 warnings recorded — scroll inside the panel to see all entries.

• Caution
• Do not re-use
• cast may be carefully loaded after 30 min.

  OTHER

• Plaster of Paris generates heat during setting reaction which can be felt by the patient. The patient should be instructed to report any pain, numbness, irritation or “burning sensation”. if the patient report any of the above, remove the cast immediately. Inspect the cast to determine the cause of the above symptoms before recasting. Burn injury may result from improper cast application or failure to observe precautions during and after setting reaction.

  OTHER

Primary placement in XI; available across 32 countries total.

Trade name

pharma pop

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.

06222023801110

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.

62220238POPUndercast3V

Reference / catalog number

PLA753000

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

casting tape

Additional information URL

No additional information URL provided by the manufacturer.

Clinical sizes

• 300 MU10
• 7.5 MU10

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

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

• M030501IMMOBILISATION BANDAGES FOR SHOULDER, ARM AND COLLARBONE

• Class I medical devices in EUDAMED

Certificate health across this manufacturer's portfolio.

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