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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

RFSU Grande XL — Class IIb MDR by RFSU AB

MD Atlas
RFSU AB

EUDAMED last updated this device on Jul 28, 2025

RFSU Grande XL

731057Condoms8C

On the marketClass IIb

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: RFSU AB
UDI-DI code: 07310571000563
Reference / catalog number: 07310571000563

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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.

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.
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.

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Market distribution

Primary placement in Sweden; available across 3 countries total.

Country	On market since	Until
SwedenPrimary placement		Still on market
Denmark		Still on market
Norway		Still on market

Device identification

Trade name: RFSU Grande XL
UDI-DI code: 07310571000563
Basic UDI-DI: 731057Condoms8C
Reference / catalog number: 07310571000563
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: Straight parallel sides, smooth and natural condom with reservoir and silicone oil. Length: 200 ± 5 mm, Width: 60 ± 2 mm, Thickness: 0,07 ± 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)07310571000563

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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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