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Sign in to claim this brandSuzhou Colourway New Material Co., Ltd.
US
Last updated September 17, 2026
What Suzhou Colourway New Material Co., Ltd. makes
The company manufactures basic male condoms made from Hevea latex, including flavored, textured, and novelty styles such as shark-shaped and ribbed varieties. These products are designed for single-use protection during sexual intercourse and are available under various brand names.
The portfolio consists of Class II medical devices, all of which are listed in the FDA’s Unique Device Identifier (UDI) database. The company operates with a presence in the United States.
Written from this company's registered devices by an AI model, and not verified by a human reviewer.
Frequently asked questions
What types of medical devices does Suzhou Colourway New Material Co., Ltd. manufacture?
Suzhou Colourway New Material Co., Ltd. specializes in basic male condoms made from Hevea latex. These include standard, flavored, textured, and novelty designs like shark-shaped or ribbed varieties, all intended for single-use protection during sexual intercourse. The focus is exclusively on this category of Class II devices.
Where is Suzhou Colourway New Material Co., Ltd. based, and does it operate in the US?
The company is based in the United States. While it operates within the US market, its regulatory presence is reflected in listings like the FDA’s Unique Device Identifier (UDI) database, which catalogs its Class II condom products for traceability and compliance tracking.
Which regulatory registries list Suzhou Colourway New Material Co., Ltd.’s devices?
The company’s devices are listed in the FDA’s Unique Device Identifier (UDI) database. This registry ensures transparency in device identification, manufacturing sourcing, and compliance with US regulatory requirements for Class II medical devices like its latex condoms.
How are Suzhou Colourway New Material Co., Ltd.’s condoms classified under medical device regulations?
The company’s male condoms fall under Class II medical device classification. This classification is assigned based on their intended use (single-use barrier protection) and associated risk level, requiring compliance with specific FDA regulations to ensure safety and performance without needing the stringent pre-market approval process reserved for higher-risk Class III devices.
AI-generated from registry data and not verified by a human reviewer.
Information
- Country
- US
- Address
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- Website
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- Phone
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- PRRC Contact
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- EUDAMED SRN
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- FDA FEI Number
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- DUNS Number
- 544612070
Catalogue (12)
| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Getane | Super smooth and moisturizing Male, medium (53 ± 2mm) thickness: 0.065 ± 0.015mm | FDA UDI | Class II | Active |
| Aowawo | 3 in 1 Male Latex Condoms, medium (53 ± 2mm) thickness: 0.065 ± 0.015mm | FDA UDI | Class II | Active |
| Getane | Extra Dotted Condoms, medium (53 ± 2mm) thickness: 0.06 ± 0.01mm | FDA UDI | Class II | Active |
| m.Dior.S Shock Shark Condoms | 53±2mm | FDA UDI | Class II | Active |
| Getane | Large size Condoms, medium (55 ± 2mm) thickness: 0.06 ± 0.01mm | FDA UDI | Class II | Active |
| m. Dior | Dotted, medium (53 ± 2mm) thickness: 0.045 ± 0.008mm | FDA UDI | Class II | Active |
| Getane | Active ribbed Male Latex Condoms, medium (53 ± 2mm) thickness: 0.065 ± 0.015mm | FDA UDI | Class II | Active |
| Getane | Ultra-thin, medium (53 ± 2mm) thickness: 0.045 ± 0.008mm | FDA UDI | Class II | Active |
| FUNfans | Ultra-thin, medium (53 ± 2mm) thickness: 0.045 ± 0.008mm | FDA UDI | Class II | Active |
| Getane | Fragrance sexy fun strawberry Male, medium (53 ± 2mm) thickness:0.065 ± 0.015mm | FDA UDI | Class II | Active |
| m. Dior | 53±2mm | FDA UDI | N/A | Unknown |
| Getane | Ice and fire Male Latex Condoms, medium (53 ± 2mm) thickness: 0.065±0.015mm | FDA UDI | Class II | Active |
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