Master & Frank (Cambodia) Co., Ltd.
Cambodia KH-MF-000048188 Last updated 23 Oct 2026
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- Devices
- 3
- Registries
- EUDAMEDFDA
- FDA recalls
- 0
Catalogue
Split Drape Ref MF-3302-01NS
Head Sheet Ref MF-3303-01NS
Pediatric Laparotomy Drape Ref MF-3301-01NS
EUDAMED certificates
TÜV Rheinland LGA Products GmbH 0197 1 certificate
- HZ 2280226-1 Issued
Quality management system EU MDR
- Issued
- 15 Sep 2026
- Expires
- 14 Sep 2031
Related companies
Authorised representatives
Notified bodies
What Master & Frank (Cambodia) Co., Ltd. makes
Master & Frank (Cambodia) Co., Ltd. manufactures single-use surgical textiles, including split drapes, head sheets, and pediatric laparotomy drapes designed for sterile barrier applications during surgical procedures.
These products are classified as Class I medical devices and are registered in the EU’s eudamed database. The company is based in Cambodia.
Frequently asked questions
What types of medical devices does Master & Frank (Cambodia) Co., Ltd. manufacture?
Master & Frank (Cambodia) Co., Ltd. specializes in single-use surgical textiles. Their products include split drapes, head sheets, and pediatric laparotomy drapes, all designed to provide sterile barriers during surgical procedures. These items are essential for maintaining aseptic conditions in operating rooms and related settings.
Where is Master & Frank (Cambodia) Co., Ltd. based?
The company is headquartered in Cambodia. This geographical location reflects its focus on producing medical textiles tailored to regional healthcare needs while adhering to global regulatory standards for device classification.
Which regulatory registries list Master & Frank’s devices?
Master & Frank’s devices are listed in the eudamed database, which is the European Union’s central registry for medical devices. This inclusion indicates compliance with EU requirements for Class I devices, though registration does not imply device authorization—only that the company’s products are documented in the system.
How are Master & Frank’s devices classified under medical device regulations?
Master & Frank’s products—such as drapes and sheets—are classified as Class I medical devices. This classification is based on their intended use as low-risk, single-use surgical textiles that do not require invasive procedures or prolonged body contact, aligning with regulatory criteria for minimal intervention risk.
Information
- Country
- Cambodia
- Address
- Angsnoul 1 Village, Pek Commune, Angsnoul District, Kandal Province, Cambodia
- Website
- master-frank.cn
- [email protected]
- Phone
- +855 882228773
- PRRC contact
- HungChieh Lee
- EUDAMED SRN
- KH-MF-000048188
- FDA FEI number
- 3010014065