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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

473011 — Class IIb MDR by Galena Pharma Oy

MD Atlas
Galena Pharma Oy

EUDAMED last updated this device on Nov 13, 2023

473011

642061571350179BT

On the marketClass IIb

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: Galena Pharma Oy
UDI-DI code: 06420615710646
Reference / catalog number: 473011

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Manufacturer information

Organization name: Galena Pharma Oy
SRN: FI-MF-000000588
Manufacturer status: Active

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350221/426001642061571350221AZOn the market 426002B-426002NFOn the market 9272084B-06418086102169On the market 9259071B-06418086101902On the market 9294700B-06418086102428On the market

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.

Critical warnings

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

CW999
Do not use the product if you are allergic or hypersensitive to any of the ingredients of this product.

Market distribution

Primary placement in Sweden; available across 1 country total.

Country	On market since	Until
SwedenPrimary placement	Dec 18, 2023	Still on market

Device identification

Trade name: not provided
UDI-DI code: 06420615710646
Basic UDI-DI: 642061571350179BT
Reference / catalog number: 473011
Issuing entity: GS1

Classification

Risk category: Class IIb
Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Status: On the market

Device details

Quantity: 1
Additional product description: Fast-acting micro-enema. It softens hard faeces without irritating the bowel. The device is used for temporary constipation, and it can also be used for emptying the bowel before rectal endoscopy.
Additional information URL: No additional information URL provided by the manufacturer.
Clinical sizes: No clinical sizes registered for this device.

EMDN nomenclature code(s)

G020301RECTAL TUBES

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