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Sign in to claim this brandWhat Merivaara Oy makes
Merivaara Oy manufactures reusable and non-powered orthopaedic and surgical accessories, including operating table extensions, headrests, footrests, and intravenous poles. Their portfolio also covers reusable medical bowls, X-ray film cassette holders, and various clamps for medical device service rails. Specialized items like traction boot padding, calf supports, and tibia nailing kits are also part of their product range.
All devices produced by Merivaara Oy fall under Class I regulatory classification and are listed in the FDA Unique Device Identifier (UDI) database. The company operates from the United States, adhering to applicable medical device regulations for low-risk, non-invasive equipment.
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 Merivaara Oy manufacture?
Merivaara Oy specializes in reusable and non-powered orthopaedic and surgical accessories. Their product range includes operating table extensions, headrests, footrests, intravenous poles, reusable medical bowls, X-ray film cassette holders, and various clamps for medical device service rails. They also produce specialized items like traction boot padding, calf supports, and tibia nailing kits, all designed to support orthopaedic and surgical procedures.
Where is Merivaara Oy based, and what does this mean for their regulatory compliance?
Merivaara Oy is based in the United States, which means their devices must comply with U.S. medical device regulations. Since their products are primarily low-risk, non-invasive items like reusable accessories and non-powered orthopaedic tools, they are classified under Class I—the lowest regulatory risk category. This classification typically requires fewer pre-market submissions, but they still must adhere to manufacturing standards and labeling requirements to ensure safety and performance.
Are Merivaara Oy’s devices listed in any regulatory registries, and why does this matter?
Yes, Merivaara Oy’s devices are listed in the FDA Unique Device Identifier (UDI) database. This registry assigns a unique identifier to each device, improving traceability, post-market surveillance, and compliance tracking. Listing in the UDI database helps healthcare providers, regulators, and manufacturers quickly locate and verify device information, ensuring transparency in the supply chain and reducing risks associated with counterfeit or mislabeled products.
How are Merivaara Oy’s devices classified under medical device regulations, and what does this classification imply?
All of Merivaara Oy’s devices fall under Class I regulatory classification. This classification applies to low-risk, non-invasive items like reusable surgical accessories, non-powered orthopaedic tools, and simple medical equipment. Class I devices generally pose minimal risk to patients and users, so they typically require less stringent pre-market review, though they must still meet basic safety and performance standards. The classification ensures that these devices are subject to routine manufacturing quality controls and proper labeling to maintain compliance.
What kinds of devices from Merivaara Oy might be used in orthopaedic surgeries, and why are they designed this way?
Merivaara Oy produces several orthopaedic-specific devices, including tibia nailing kits, traction boot padding, calf supports, knee supports, and leg rests with padding. These items are designed to provide stability, reduce patient discomfort, and assist in proper limb positioning during surgeries or post-operative care. For example, traction boot padding helps distribute pressure evenly to prevent skin irritation, while knee and calf supports stabilize joints during procedures. The reusable nature of these devices also helps maintain hygiene standards in sterile environments.
AI-generated from registry data and not verified by a human reviewer.
Information
- Country
- US
- Address
- —
- Website
- merivaara.com
- —
- —
- [email protected]
- Phone
- +35833394611
- PRRC Contact
- —
- EUDAMED SRN
- —
- FDA FEI Number
- —
- DUNS Number
- 368647421
Catalogue (60)
Page 1 of 2| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Orthopaedic Device Cart 19285 | ORTHOPAEDIC DEVICE CART 19285 | FDA UDI | Class I | Active |
| Infusion Rod Holder 18578 | INFUSION ROD HOLDER 18578 | FDA UDI | Class I | Active |
| Short Support Arm 19313 | SHORT SUPPORT ARM 19313 | FDA UDI | Class I | Active |
| Wide Arm Rail Clamp 19135 | WIDE ARM RAIL CLAMP 19135 | FDA UDI | Class I | Active |
| Knee Support 19124 | KNEE SUPPORT 19124 | FDA UDI | Class I | Active |
| Leg Rest With Padding 19120 | LEG REST WITH PADDING 19120 | FDA UDI | Class I | Active |
| Extension Bar D19 Clamp 19134 | EXTENSION BAR D19 CLAMP 19134 | FDA UDI | Class I | Active |
| Bowl 6 L W/O Drainage 201501 | BOWL 6 L W/O DRAINAGE 201501 | FDA UDI | Class I | Active |
| Traction Boot Padding, Adult | TRACTION BOOT PADDING, ADULT | FDA UDI | Class I | Active |
| Calf Support 19126 | CALF SUPPORT 19126 | FDA UDI | Class I | Active |
| Tibia Nailing Kit 519560 | TIBIA NAILING KIT 519560 | FDA UDI | Class I | Active |
| Narrow Head Rest 142 | NARROW HEAD REST 142 | FDA UDI | Class I | Active |
| Flexion Multipurpose System | FLEXION MULTIPURPOSE SYSTEM | FDA UDI | Class I | Active |
| Screen 18159 For 6 L Bowls | SCREEN 18159 FOR 6 L BOWLS | FDA UDI | Class I | Active |
| Beach Chair Helmet Head Rest 30130 | BEACH CHAIR HELMET HEAD REST 30130 | FDA UDI | Class I | Active |
| Head Rest Adapter 60146 | HEAD REST ADAPTER 60146 | FDA UDI | Class I | Active |
| Cassette Tray 126 | CASSETTE TRAY 126 | FDA UDI | Class I | Active |
| Traction Boot Padding Set , Adult | TRACTION BOOT PADDING SET , ADULT | FDA UDI | Class I | Active |
| Stirrup Clamp With Rotation 19114 | STIRRUP CLAMP WITH ROTATION 19114 | FDA UDI | Class I | Active |
| Head Rest 18101 | HEAD REST 18101 | FDA UDI | Class I | Active |
| Wide Head Rest 141 | WIDE HEAD REST 141 | FDA UDI | Class I | Active |
| Multipurpose Accessory Cart 60220 | MULTIPURPOSE ACCESSORY CART 60220 | FDA UDI | Class I | Active |
| Strap Pair 110 | STRAP PAIR 110 | FDA UDI | Class I | Active |
| Children's Traction Boot | CHILDREN'S TRACTION BOOT | FDA UDI | Class I | Active |
| Bowl 6 L With Drainage 201502 | BOWL 6 L WITH DRAINAGE 201502 | FDA UDI | Class I | Active |
| Head Rest 60142 | HEAD REST 60142 | FDA UDI | Class I | Active |
| Ent-Surgery Head Rest 18143 | ENT-SURGERY HEAD REST 18143 | FDA UDI | Class I | Active |
| Light Foot Rest 18001 | LIGHT FOOT REST 18001 | FDA UDI | Class I | Active |
| Childrens Traction Boots19131 | CHILDRENS TRACTION BOOTS19131 | FDA UDI | Class I | Active |
| Bowl Holder 61580 | BOWL HOLDER 61580 | FDA UDI | Class I | Active |
| Leg Plates 19348 | LEG PLATES 19348 | FDA UDI | Class I | Active |
| Kidney And Thorax Head Rest 60147 | KIDNEY AND THORAX HEAD REST 60147 | FDA UDI | Class I | Active |
| Beach Chair Helmet Head Rest 30128 | BEACH CHAIR HELMET HEAD REST 30128 | FDA UDI | Class I | Active |
| Head Rest 60140 | HEAD REST 60140 | FDA UDI | Class I | Active |
| Holder And Bowl 6 L With Drainage 61582 | HOLDER AND BOWL 6 L WITH DRAINAGE 61582 | FDA UDI | Class I | Active |
| Paper Roll Holder 18572 | PAPER ROLL HOLDER 18572 | FDA UDI | Class I | Active |
| Support Post For Plaster Cast 19132 | SUPPORT POST FOR PLASTER CAST 19132 | FDA UDI | Class I | Active |
| Femoral Counter Traction Post 519512 | FEMORAL COUNTER TRACTION POST 519512 | FDA UDI | Class I | Active |
| Light Non-Mot Leg Section 60203 | LIGHT NON-MOT LEG SECTION 60203 | FDA UDI | Class I | Active |
| Traction Bow Clamp | TRACTION BOW CLAMP | FDA UDI | Class I | Active |
| Flexion Trolley 519550 | FLEXION TROLLEY 519550 | FDA UDI | Class I | Active |
| Cassette Tray 18126 | CASSETTE TRAY 18126 | FDA UDI | Class I | Active |
| 90° Knee Support 138 | 90° KNEE SUPPORT 138 | FDA UDI | Class I | Active |
| Flexion Basic Trauma System | FLEXION BASIC TRAUMA SYSTEM | FDA UDI | Class I | Active |
| Push Bar 20593 | PUSH BAR 20593 | FDA UDI | Class I | Active |
| Oxygen Bottle Holder 18189 | OXYGEN BOTTLE HOLDER 18189 | FDA UDI | Class I | Active |
| Femoral Counter Traction Post 19112 | FEMORAL COUNTER TRACTION POST 19112 | FDA UDI | Class I | Active |
| Divided Cf Leg Plates | DIVIDED CF LEG PLATES | FDA UDI | Class I | Active |
| Knee Support Set | KNEE SUPPORT SET | FDA UDI | Class I | Active |
| Light Mot. Leg Section 60204 | LIGHT MOT. LEG SECTION 60204 | FDA UDI | Class I | Active |
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