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Sign in to claim this brandAvaline Medical NJ Limited Liability Company
US
Last updated May 24, 2026
What Avaline Medical NJ Limited Liability Company makes
The company produces non-woven gauze pads, multi-purpose surgical skin adhesive tapes, and adhesive bandages for wound care and minor surgical applications. It also manufactures single-use urine specimen collection kits for in vitro diagnostic use, unscented menstrual pads, reusable absorbent underpads, and ankle binders for medical or mobility support. Medicine cups for single-use dosing are part of its portfolio, catering to clinical and patient needs.
All listed devices fall under Class I regulatory classification in the US, with each product authorised via the FDA’s UDI (Unique Device Identification) system. The company is based in the United States and adheres to US regulatory requirements for these medical and personal care items.
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 Avaline Medical NJ Limited Liability Company manufacture?
Avaline Medical NJ Limited Liability Company produces a range of medical and personal care devices, including non-woven gauze pads for wound care, multi-purpose surgical skin adhesive tapes, and adhesive bandages for minor surgical applications. It also manufactures single-use urine specimen collection kits for in vitro diagnostic (IVD) use, unscented menstrual pads, reusable absorbent underpads, ankle binders for mobility support, and single-use medicine cups for clinical dosing. These products address wound care, hygiene, specimen collection, and patient comfort needs.
Where is Avaline Medical NJ Limited Liability Company based, and how does this affect its regulatory compliance?
Avaline Medical NJ Limited Liability Company is based in the United States, which means its devices must comply with US regulatory requirements. Since all its listed devices fall under Class I classification, they are subject to the FDA’s Unique Device Identification (UDI) system for traceability and authorisation. The company ensures its products meet US standards for safety and performance, as required by the FDA’s regulatory framework.
Which regulatory registries or databases list Avaline Medical NJ Limited Liability Company’s devices?
Avaline Medical NJ Limited Liability Company’s devices are listed in the FDA’s UDI (Unique Device Identification) database, which is the primary US registry for tracking and authorising medical devices. The UDI system ensures transparency in device identification, regulatory compliance, and market surveillance. This listing confirms the devices have been authorised under US regulatory requirements.
How are Avaline Medical NJ Limited Liability Company’s devices classified under US regulations?
All of Avaline Medical NJ Limited Liability Company’s listed devices fall under Class I classification in the US. This classification applies to low-risk medical devices that pose minimal potential harm to patients. Class I devices are generally exempt from premarket approval but must still comply with FDA registration, UDI requirements, and other applicable regulations to ensure safety and proper use.
Why are Avaline Medical NJ Limited Liability Company’s devices authorised via the FDA’s UDI system?
The FDA’s UDI system is used to uniquely identify Avaline Medical NJ Limited Liability Company’s devices, ensuring traceability, transparency, and compliance with US regulatory standards. Since these devices are Class I, they do not require premarket approval but must still be registered and listed in the UDI database to demonstrate they meet FDA requirements for safety, performance, and proper labeling. This system helps healthcare providers and regulators track devices throughout their lifecycle.
AI-generated from registry data and not verified by a human reviewer.
Information
- Country
- US
- Address
- —
- Website
- avalinemedical.com
- —
- —
- [email protected]
- Phone
- +1(732)813-7799
- PRRC Contact
- —
- EUDAMED SRN
- —
- FDA FEI Number
- —
- DUNS Number
- 079767953
Catalogue (490)
Page 4 of 10| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Avaline Medical NJ LLC | ST12P4X42400 | FDA UDI | Class I | Active |
| Avaline Medical NJ LLC | NWNS4P4X4200 | FDA UDI | Class I | Active |
| Avaline Medical NJ LLC | ET x2 | FDA UDI | Class I | Active |
| Avaline Medical NJ LLC | 2x3510 + VT | FDA UDI | Class I | Active |
| Avaline Medical NJ LLC | vkmp40 | FDA UDI | Class I | Active |
| Avaline Medical NJ LLC | PL M-CUPx2 | FDA UDI | Class I | Active |
| Avaline Medical NJ LLC | vk048tb | FDA UDI | Class I | Active |
| Avaline Medical NJ LLC | 2ozX160 | FDA UDI | Class I | Active |
| Avaline Medical NJ LLC | DS40X48X100 | FDA UDI | Class I | Active |
| Avaline Medical NJ LLC | EMWSC 3x3 | FDA UDI | Class I | Active |
| Avaline Medical NJ LLC | NS4P3x3 600 | FDA UDI | Class I | Active |
| Avaline Medical NJ LLC | NWST4P4X4100 | FDA UDI | Class I | Active |
| Avaline Medical NJ LLC | KNB BL 100 | FDA UDI | Class I | Active |
| Avaline Medical NJ LLC | KNB BL 200 | FDA UDI | Class I | Active |
| Avaline Medical NJ LLC | HEP1.2 | FDA UDI | Class I | Active |
| Avaline Medical NJ LLC | vkssc10 | FDA UDI | Class I | Active |
| Avaline Medical NJ LLC | LGCBx10 | FDA UDI | Class I | Active |
| Avaline Medical NJ LLC | NWST4P2X600 | FDA UDI | Class I | Active |
| Avaline Medical NJ LLC | st2inx4 | FDA UDI | Class I | Active |
| Avaline Medical NJ LLC | SPAN x20 | FDA UDI | Class I | Active |
| Avaline Medical NJ LLC | LG100BWC | FDA UDI | Class I | Active |
| Avaline Medical NJ LLC | 5x9x10 | FDA UDI | Class I | Active |
| Avaline Medical NJ LLC | 2in+DIP +1 | FDA UDI | Class I | Active |
| Avaline Medical NJ LLC | 44x52 x10 | FDA UDI | Class I | Active |
| Avaline Medical NJ LLC | NAP2X3x100 | FDA UDI | Class I | Active |
| Avaline Medical NJ LLC | 8x7.5x24 | FDA UDI | Class I | Active |
| Avaline Medical NJ LLC | 10P NSG 4x4 | FDA UDI | Class I | Active |
| Avaline Medical NJ LLC | ST GP 3x3 | FDA UDI | Class I | Active |
| Avaline Medical NJ LLC | VKDT x100 | FDA UDI | Class I | Active |
| Avaline Medical NJ LLC | VKEBS | FDA UDI | Class I | Active |
| Avaline Medical NJ LLC | vkssc03 | FDA UDI | Class I | Active |
| Avaline Medical NJ LLC | NAP 3X8 x1200 | FDA UDI | Class I | Active |
| Avaline Medical NJ LLC | NAP 3X8 x300 | FDA UDI | Class I | Active |
| Avaline Medical NJ LLC | ST 2IN X12 | FDA UDI | Class I | Active |
| Avaline Medical NJ LLC | NAP 3X8 x600 | FDA UDI | Class I | Active |
| Avaline Medical NJ LLC | PTx144 | FDA UDI | Class I | Active |
| Avaline Medical NJ LLC | st3inx96 | FDA UDI | Class I | Active |
| Avaline Medical NJ LLC | 5x9x400 | FDA UDI | Class I | Active |
| Avaline Medical NJ LLC | ST12P4X41200 | FDA UDI | Class I | Active |
| Avaline Medical NJ LLC | VKPCP0100 | FDA UDI | Class I | Active |
| Avaline Medical NJ LLC | NAP2X3x600 | FDA UDI | Class I | Active |
| Avaline Medical NJ LLC | 3436Rx10+vig | FDA UDI | Class I | Active |
| Avaline Medical NJ LLC | 4610x1+VT | FDA UDI | Class I | Active |
| Avaline Medical NJ LLC | VKAEP480 | FDA UDI | Class I | Active |
| Avaline Medical NJ LLC | IBP3X11 | FDA UDI | Class I | Active |
| Avaline Medical NJ LLC | TRAN 2inMT x8 | FDA UDI | Class I | Active |
| Avaline Medical NJ LLC | SSBAN 3607 x12 | FDA UDI | Class I | Active |
| Avaline Medical NJ LLC | tri-ban6 | FDA UDI | Class I | Active |
| Avaline Medical NJ LLC | XTR 5x9 x100 | FDA UDI | Class I | Active |
| Avaline Medical NJ LLC | XTR 5x9 x50 | FDA UDI | Class I | Active |
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