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Our data is continuously updated and sourced from EUDAMED, the European database for medical devices and in vitro diagnostics.

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Organization name
UDI-DI code
Reference / catalog number

GUM Ortho Wax — Class I MDR by Sunstar Europe SA

MD Atlas
Sunstar Europe SA

EUDAMED last updated this device on Jun 10, 2022

GUM Ortho Wax

76300199GUMORTHOWAXLV

On the marketClass I

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: Sunstar Europe SA
UDI-DI code: 17630019900017
Reference / catalog number: 723BX

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Manufacturer information

Organization name: Sunstar Europe SA
SRN: CH-MF-000023162
Manufacturer status: Active

Critical warnings

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

CW999
Do not use in the presence of hypersensitivity to any ingredients contained in the product

Market distribution

Primary placement in Spain; available across 1 country total.

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

Device identification

Trade name: GUM Ortho Wax
UDI-DI code: 17630019900017
Basic UDI-DI: 76300199GUMORTHOWAXLV
Reference / catalog number: 723BX
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: GUM Orthodontic Wax is a device used to create a physical barrier between the orthodontic appliance and the oral soft tissues to prevent lesions and alleviate irritations on orthodontic appliances users.
Additional information URL: No additional information URL provided by the manufacturer.
Clinical sizes: No clinical sizes registered for this device.

EMDN nomenclature code(s)

Q01020203OCCLUSAL WAXES

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

Batch number
Expiration date
Manufacturing date
Serial number
Software identification

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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.