Pricing Sign in

Role
Country
Date of registration
Address

Made In Tracker

Made In Tracker EasyUDI

Legal

Privacy Policy Legal Notice

About

About FAQ Partners 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

RFSU For the freedoom of ..Green — Class IIb MDR by RFSU AB

MD Atlas
RFSU AB

EUDAMED last updated this device on Jul 29, 2025

RFSU For the freedoom of ..Green

731057Condoms8C

On the marketClass IIb

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: RFSU AB
UDI-DI code: 07310571000853
Reference / catalog number: 07310571000853

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?

View device family (Basic UDI)

Manufacturer information

Organization name: RFSU AB
SRN: SE-MF-000008574
Manufacturer status: Active

Related devices

Plan Blå731057Condoms8COn the market Plan Budget731057Condoms8COn the market Plan Grön731057Condoms8COn the market Plan Gul731057Condoms8COn the market Plan Lila731057Condoms8COn 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

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

CW007
If the package is damaged, discard the condom and take a new condom from an undamaged package.
CW129
Contains natural rubber latex, which may cause allergic reaction including anaphylactic shock.
CW010
Read the instruction for use carefully before use.
CW009
Condoms are for single use only. Re-use of condom can increase the risk of breakage and infection.

EasyUDICompliance engine

Sponsored

Your devices, UDI-compliant — without drowning in regulation

EUDAMED-ready· UDI-enriched

Basic UDIUDI-DIUDI-PIAttributeDocument

Print-ready label

From your product file — no manual entry

Exclusive to MD Atlas usersClaim my −20% discount

by Made In Tracker

Market distribution

Primary placement in Sweden; available across 1 country total.

Country	On market since	Until
SwedenPrimary placement		Still on market

Device identification

Trade name: RFSU For the freedoom of ..Green
UDI-DI code: 07310571000853
Basic UDI-DI: 731057Condoms8C
Reference / catalog number: 07310571000853
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: Profiled, dotted and natural condom with reservoir and silicone oil. Length: 185 ± 5 mm, Width: 52 ± 2 mm, Thickness: 0,06 ± 0,007 mm
Additional information URL: No additional information URL provided by the manufacturer.
Clinical sizes: No clinical sizes registered for this device.

UDI-PI traceability

Batch number
Expiration date
Manufacturing date
Serial number
Software identification

UDI-DI DataMatrix

Encoded

(01)07310571000853

Sign in to download the DataMatrix

Create a free account to download the UDI-DI DataMatrix for this device.

Email

Password

No account yet?

UDI-PI DataMatrix

The compliance carrier: encodes the device identifier plus the production identifiers (lot, serial, dates) registered for this device.

Sign in to generate the UDI-PI DataMatrix

Create a free account, then generate the compliant UDI-PI carrier for this device.

Email

Password

No account yet?

EMDN nomenclature code(s)

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

U110101CONDOMS

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

Become a partner of MD Atlas