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

Cannula Fixation Dressing — Class I MDR by Sopharma AD

MD Atlas
Sopharma AD

EUDAMED last updated this device on Aug 31, 2022

Cannula Fixation Dressing

3800010632001593

On the marketClass I

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: Sopharma AD
UDI-DI code: 03800728497840
Reference / catalog number: 32001000-0115

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: Sopharma AD
SRN: BG-MF-000019983
Manufacturer status: Active

Related devices

Bandages Comfort3800010632002494On the market Bandages Comfort3800010632002494On the market Bandages Comfort3800010632002494On the market Bandages Ideal3800010632002494On the market Bandages Ideal3800010632002494On 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

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

CW007
The dressing shall not be used if the integrity of the package has been compromised.
CW009
The product is for single use.
CW011
Apply to clean and dry skin only.

Market distribution

Primary placement in Bulgaria; available across 1 country total.

Country	On market since	Until
BulgariaPrimary placement	May 21, 2021	Jul 12, 2024

Device identification

Trade name: Cannula Fixation Dressing
UDI-DI code: 03800728497840
Basic UDI-DI: 3800010632001593
Reference / catalog number: 32001000-0115
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: 50
Additional product description: Self-adhesive sterile dressing for I.V. cannula fixation - 6 cm x 8 cm;
Additional information URL: No additional information URL provided by the manufacturer.
Clinical sizes: No clinical sizes registered for this device.

EMDN nomenclature code(s)

M04010202POLYURETHANE FIXING 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