Identity
- Trade Name
- XO! Hi-Sensation EUDAMEDXO! FDA UDI
- Generic Name
- Basic male condom, Hevea-latex FDA UDI
- Device Name
- Non-Medicated Natural Latex Condoms EUDAMEDNatural latex male condom. Transparent, anatomical shaped, nominal width 56 mm, textured with reservoir. Lubricated with silicone oil. 100% electronically tested.” FDA UDI
- Model / Reference
- QA-224 EUDAMEDHi-Sensation 6's FDA UDI
- Description
- Natural latex male condom. Transparent, anatomical shaped, nominal width 56 mm, textured with reservoir. Lubricated with silicone oil. 100% electronically tested.” FDA UDI
Identifiers
- Catalog Number
- QA-224 FDA UDI
- Primary DI / UDI-DI
- 29556807352255 EUDAMEDFDA UDI
- Basic UDI-DI
- 9556807CD001UF EUDAMED
- Direct Marketing DI
- 29556807352255 EUDAMED
- 510(k) Number
- K070511 FDA UDI
- FDA Product Code
- HIS FDA UDI
- EMDN Code
- U110101 CONDOMS EUDAMED
- GMDN Term
- Basic male condom, Hevea-latex FDA UDI
Classification
- Device Class
- Class IIb EUDAMEDClass II FDA UDI
- Regulation Number
- 884.5300 FDA UDI
- Market of Registration
- Northern Ireland EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
Yes
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
Yes
EUDAMEDFDA UDI
Reprocessed
No
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Prescription Use
No
FDA UDI
Over-the-Counter
Yes
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
XO! Hi-Sensation by Richter Rubber Technology Sdn. Bhd. — Class IIb — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 9556807CD001UF | Class IIb | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIb | Pending data |
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Manufacturer
- Manufacturer
- Richter Rubber Technology Sdn Bhd
- EUDAMED SRN
- MY-MF-000023324
- Authorised Representative
- rrt Vertrieb und Service GmbH DE-AR-000021443
Sources (2)
- EUDAMED d93f4c66-fd58-4393-be86-ee0ff0698d35 61 fields · synced Jun 19, 2026
- FDA UDI 447bb90f-5492-4394-b0e8-bfe70d90bf7c 36 fields · synced May 29, 2026