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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

Plan Gul — Class IIb MDR by RFSU AB

MD Atlas
RFSU AB

EUDAMED last updated this device on Jul 28, 2025

Plan Gul

731057Condoms8C

On the marketClass IIb

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: RFSU AB
UDI-DI code: 05709556758452
Reference / catalog number: 05709556758452

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View device family (Basic UDI)

Manufacturer information

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

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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.

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.

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Market distribution

Primary placement in Denmark; available across 1 country total.

Country	On market since	Until
DenmarkPrimary placement		Still on market

Device identification

Trade name: Plan Gul
UDI-DI code: 05709556758452
Basic UDI-DI: 731057Condoms8C
Reference / catalog number: 05709556758452
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, smooth and natural condom with reservoir and silicone oil. Length: 185 ± 5 mm, Width: 53 ± 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)05709556758452

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UDI-PI DataMatrix

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

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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

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