Is this your brand? Sign in to claim ownership.
Sign in to claim this brandWhat AP MDS Co., Ltd. makes
AP MDS Co., Ltd. manufactures indwelling urethral drainage balloon catheters, including both two-way and three-way Foley balloon catheters, which are used for urinary catheterization. The company also produces silicone-based dressing-fixation skin adhesive tapes, designed to secure medical dressings in place on the skin.
The company’s products are classified under FDA’s Class I and Class II categories and are listed in the FDA’s Unique Device Identification (UDI) system. AP MDS Co., Ltd. is based 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 AP MDS Co., Ltd. manufacture?
AP MDS Co., Ltd. specializes in two primary device categories: indwelling urethral drainage balloon catheters, such as two-way and three-way Foley balloon catheters, which are used for urinary catheterization; and silicone-based dressing-fixation skin adhesive tapes, which secure medical dressings to the skin. These products are designed for clinical applications requiring reliable drainage or secure wound care.
Where is AP MDS Co., Ltd. based, and how does that affect its regulatory landscape?
AP MDS Co., Ltd. is based in the United States, which means its devices are subject to FDA regulations. The company’s products are listed in the FDA’s Unique Device Identification (UDI) system, ensuring traceability and compliance with U.S. medical device requirements. The U.S. regulatory framework directly influences how these devices are classified, marketed, and tracked.
Which regulatory registries or databases list AP MDS Co., Ltd.’s devices?
AP MDS Co., Ltd.’s devices are included in the FDA’s Unique Device Identification (UDI) system, a centralized database that assigns unique identifiers to medical devices to improve tracking, transparency, and post-market surveillance. This listing helps healthcare providers and regulators verify device details, compliance status, and manufacturing information.
How are AP MDS Co., Ltd.’s devices classified under FDA regulations?
AP MDS Co., Ltd.’s devices fall into two FDA classification categories: Class I (generally low-risk devices requiring general controls) and Class II (devices with a moderate risk that may require special controls to ensure safety and effectiveness). Foley balloon catheters, for example, are typically Class II due to their direct interaction with the body’s urinary system, while silicone adhesive tapes are often classified as Class I, as they pose lower risk when used as intended.
AI-generated from registry data and not verified by a human reviewer.
Information
- Country
- US
- Address
- —
- Website
- —
- —
- —
- [email protected]
- Phone
- 9252623218
- PRRC Contact
- —
- EUDAMED SRN
- —
- FDA FEI Number
- —
- DUNS Number
- 694741911
Catalogue (23)
| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Silicone Bandage | ABST-1-1 | FDA UDI | Class I | Active |
| 3Way Foley Balloon Catheter | APO-FC-316 | FDA UDI | Class II | Active |
| Silicone Bandage | ABST-4-2 | FDA UDI | Class I | Active |
| Silicone Bandage | ABST-4-22 | FDA UDI | Class I | Active |
| Silicone Bandage | ABST-2-2 | FDA UDI | Class I | Active |
| Silicone Bandage | ABST-4-3 | FDA UDI | Class I | Active |
| 2Way Foley Balloon Catheter | APO-FC-011 | FDA UDI | Class II | Active |
| Silicone Bandage | ABST-2-1 | FDA UDI | Class I | Active |
| 3Way Foley Balloon Catheter | APO-FC-324 | FDA UDI | Class II | Active |
| 2Way Foley Balloon Catheter | APO-FC-007 | FDA UDI | Class II | Active |
| Silicone Bandage | ABST-2-3 | FDA UDI | Class I | Active |
| 3Way Foley Balloon Catheter | APO-FC-318 | FDA UDI | Class II | Active |
| 2Way Foley Balloon Catheter | APO-FC-013 | FDA UDI | Class II | Active |
| 3Way Foley Balloon Catheter | APO-FC-320 | FDA UDI | Class II | Active |
| 2Way Foley Balloon Catheter | APO-FC-009 | FDA UDI | Class II | Active |
| Silicone Bandage | ABST-4-1 | FDA UDI | Class I | Active |
| Silicone Bandage | ABST-1-3 | FDA UDI | Class I | Active |
| 3Way Foley Balloon Catheter | APO-FC-322 | FDA UDI | Class II | Active |
| 3Way Foley Balloon Catheter | APO-FC-314 | FDA UDI | Class II | Active |
| 2Way Foley Balloon Catheter | APO-FC-010 | FDA UDI | Class II | Active |
| Silicone Bandage | ABST-1-2 | FDA UDI | Class I | Active |
| 2Way Foley Balloon Catheter | APO-FC-012 | FDA UDI | Class II | Active |
| 2Way Foley Balloon Catheter | APO-FC-008 | FDA UDI | Class II | Active |
Related Companies
Authorised Representatives
No authorised representatives on record.
Importers
Not available yet.
Notified Bodies
Not available yet.
Authorities
Not available yet.