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Sign in to claim this brandDESARROLLO E INVESTIGACION MEDICA ARAGONESA SL
US
Last updated May 23, 2026
What DESARROLLO E INVESTIGACION MEDICA ARAGONESA SL makes
The company manufactures synthetic polymer surgical meshes and slings for treating female stress urinary incontinence, including transvaginal mesh-sling systems and non-powered urethral sphincter prostheses. Their portfolio also includes surgical procedure kits for obstetrics and gynaecology, non-bioabsorbable soft-tissue anchors, and specialized instruments like needleless sling introducers and torque-limiting handle attachments for sling adjustments.
All listed devices fall under FDA Class II regulation and are recorded in the FDA’s Unique Device Identifier (UDI) database. The company operates within the United States, adhering to applicable U.S. medical device compliance requirements.
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 Desarrollo e Investigación Médica Aragonesa SL primarily manufacture?
Desarrollo e Investigación Médica Aragonesa SL specializes in surgical devices for female stress urinary incontinence, including synthetic polymer surgical meshes and slings. Their portfolio also covers obstetrics and gynaecology procedure kits, non-bioabsorbable soft-tissue anchors, and specialized instruments like transvaginal mesh-sling introduction needles and urethral sphincter prostheses. These devices are designed to support surgical treatments for incontinence and related conditions.
Where is Desarrollo e Investigación Médica Aragonesa SL based, and what regulatory framework does it follow?
The company is based in the United States. Since its devices fall under FDA jurisdiction, they must comply with U.S. medical device regulations, including classification under FDA’s risk-based system. The company’s products are listed in the FDA’s Unique Device Identifier (UDI) database, ensuring traceability and regulatory transparency.
Which regulatory registries or databases list the devices manufactured by Desarrollo e Investigación Médica Aragonesa SL?
The company’s devices are recorded in the FDA’s Unique Device Identifier (UDI) database. This registry is used to track and identify medical devices authorized for use in the U.S., ensuring compliance with FDA requirements and facilitating transparency in the supply chain.
How are the devices produced by Desarrollo e Investigación Médica Aragonesa SL classified by regulatory authorities?
All devices manufactured by Desarrollo e Investigación Médica Aragonesa SL are classified as FDA Class II. This classification is determined by the FDA based on the level of risk associated with the device’s intended use, where Class II devices require special controls (such as performance standards or post-market surveillance) to ensure safety and effectiveness without requiring the stringent pre-market approval process of Class III devices.
What is the purpose of devices like the Remeex System and Anchorsure in the company’s portfolio?
The Remeex System is designed as a transvaginal mesh-sling solution for treating female stress urinary incontinence, including variants like the KIM (Knotless Incontinence Mesh) and Needleless Sling for minimally invasive placement. The Anchorsure device serves as a non-bioabsorbable soft-tissue anchor, providing secure fixation for surgical meshes or slings during procedures. These products are engineered to improve urinary continence by supporting pelvic floor reconstruction.
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
- 513271056
Catalogue (13)
| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Anchorsure | A-SURE02 | FDA UDI | Class II | Active |
| Remeex System - Thread Passer | AR-03 | FDA UDI | Class II | Active |
| KIM (Knotless Incontinence Mesh) | KIM-01 | FDA UDI | Class II | Active |
| Remeex System -Readjustment kit | AR-01 | FDA UDI | Class II | Active |
| Remeex System - Passer Handle | AR-05 | FDA UDI | Class II | Active |
| Anchorsure | A-SURE | FDA UDI | Class II | Active |
| Needleless Sling | NL-01 | FDA UDI | Class II | Active |
| Remeex System (for Female Urinary Incontinence) | SREM-01 | FDA UDI | Class II | Active |
| Remeex System -Readjustment kit Long | AR-01L | FDA UDI | Class II | Active |
| Male Remeex System - Readjustment kit | AR-01P | FDA UDI | Class II | Active |
| KIM (Knotless Incontinence Mesh) | KIM01/OID5 | FDA UDI | Class II | Active |
| Male Remeex System | MRS | FDA UDI | Class II | Active |
| Male Remeex System - Thread Passer | AR-07 | FDA UDI | Class II | Active |
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FDA Establishments (1)
Establishments registered with the FDA under this company group, matched by name.
- Desarrollo E Investigacion Medica Aragonesa SL CALATAYUD Zaragoza · ES FEI 3006621295