Pricing Sign in

Role
Country
Date of registration
Address

Made In Tracker

Made In Tracker EasyUDI

Legal

Privacy Policy Legal Notice

About

About FAQ Contact

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

Subscribe to our monthly newsletter:

By subscribing, you accept the General Personal Data Protection Policy.

Organization name
UDI-DI code
Reference / catalog number

9272084 — Class IIa MDD by Galena Pharma Oy

MD Atlas
Galena Pharma Oy

EUDAMED last updated this device on Nov 30, 2021

9272084

B-06418086102169

On the marketClass IIa

Applicable legislation: MDD [Directive 93/42/EEC on medical devices]
Organization name: Galena Pharma Oy
UDI-DI code: 06418086102169
Reference / catalog number: 9272084

Sign in to open the EUDAMED record

The link to the official EUDAMED page is reserved for signed-in users. Create a free account to continue.

Email

Password

No account yet?

Manufacturer information

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

Related devices

350221/426001642061571350221AZOn the market 426002B-426002NFOn the market 9259071B-06418086101902On the market 9294700B-06418086102428On the market 9289816B-06418086102374On the market

Market distribution

Primary placement in Finland; available across 1 country total.

Country	On market since	Until
FinlandPrimary placement	Mar 11, 2019	Still on market

Device identification

Trade name: not provided
UDI-DI code: 06418086102169
Basic UDI-DI: B-06418086102169
Reference / catalog number: 9272084
Issuing entity: GS1

Classification

Risk category: Class IIa
Applicable legislation: MDD [Directive 93/42/EEC on medical devices]
Status: On the market

Device details

Quantity: 1
Additional product description: Wound cleaning solution
Additional information URL: No additional information URL provided by the manufacturer.
Clinical sizes: No clinical sizes registered for this device.

EMDN nomenclature code(s)

M040412ANTISEPTICS-BASED DRESSINGS

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

Certificates

Certificate health across this manufacturer's portfolio.

CR-03-1162-806-22Supplemented
Quality management systemNotified body: 0537Expiry: Jun 30, 2027