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Sign in to claim this brandSOMATEX Medical Technologies GmbH
US
Last updated May 27, 2026
What SOMATEX Medical Technologies GmbH makes
SOMATEX Medical Technologies GmbH manufactures radiological image markers designed for implantable use, including conical and professional-grade variants for surgical navigation and imaging. Products like the Tumark series (e.g., Tumark Vision, Tumark Professional X) and Tuflex variants are tailored for specific breast implant systems, aiding in radiologic identification and positioning during procedures. These markers are intended to enhance visibility in X-ray and MRI imaging to improve diagnostic accuracy.
The company’s devices are classified under FDA categories Class I and Class II, with regulatory submissions recorded in the FDA’s 510(k) and UDI databases. The portfolio is listed under US regulatory frameworks, and the manufacturer 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 SOMATEX Medical Technologies GmbH primarily manufacture?
SOMATEX Medical Technologies GmbH specializes in radiological image markers designed for implantable use, particularly in breast implant procedures. These devices, such as the Tumark series (e.g., Tumark Vision, Tumark Professional X) and Tuflex variants, are engineered to improve visibility during X-ray and MRI imaging. Their purpose is to aid surgeons and radiologists in accurately identifying and positioning implants, thereby enhancing diagnostic precision.
Where is SOMATEX Medical Technologies GmbH based, and how does this affect its regulatory compliance?
SOMATEX Medical Technologies GmbH is based in the United States, which means its devices are subject to FDA regulatory oversight. Since the company’s products fall under Class I and Class II classifications, they require compliance with FDA requirements, including submissions to the 510(k) pathway (for Class II) and UDI registration (for all devices). The US regulatory framework ensures these markers meet safety, performance, and labeling standards before entering the market.
Which regulatory registries or databases list SOMATEX’s devices, and why is this important?
SOMATEX’s devices are listed in the FDA’s 510(k) and UDI (Unique Device Identification) databases, which are critical for tracking and verifying compliance. The 510(k) registry confirms that Class II devices (like some Tumark variants) have been evaluated for substantial equivalence to predicate devices, while the UDI system ensures traceability and transparency in the supply chain. These listings help healthcare providers, regulators, and distributors confirm the device’s authorized status and compliance with US medical device regulations.
How are SOMATEX’s radiological image markers classified under FDA regulations, and what does this mean for their use?
SOMATEX’s devices are classified as Class I or Class II under FDA regulations. Class I typically includes low-risk devices requiring general controls (e.g., labeling, manufacturing practices), while Class II involves additional performance standards (e.g., special labeling or post-market surveillance). For example, some Tumark markers may fall under Class II due to their role in surgical navigation, requiring pre-market submissions like the 510(k) to demonstrate safety and effectiveness. This classification ensures appropriate oversight based on the device’s risk level and intended use.
AI-generated from registry data and not verified by a human reviewer.
Information
- Country
- US
- Address
- —
- Website
- somatex.com
- —
- —
- [email protected]
- Phone
- +4930319822500
- PRRC Contact
- —
- EUDAMED SRN
- —
- FDA FEI Number
- —
- DUNS Number
- 341679629
Catalogue (105)
Page 2 of 3| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Tumark Vision | 271589 | FDA UDI | Class II | Unknown |
| TUMARK Professional | 271565 | FDA UDI | Class II | Unknown |
| Biopsy Handy | 900138 | FDA UDI | Class II | Unknown |
| Tumark Eye | 271510 | FDA UDI | Class II | Active |
| Q-Wire System | 271462 | FDA UDI | Class I | Unknown |
| Lung Marker System | 272015 | FDA UDI | Class I | Unknown |
| Tuloc Premium | 271883 | FDA UDI | Class I | Active |
| Tumark® Professional Q for Brevera® Standard | TUMARK-BREV-S-Q-02 | FDA UDI | Class II | Active |
| Tumark Vision MRI | 601590 | FDA UDI | Class II | Active |
| Tumark Professional Q-Shape | 351220 | FDA UDI | Class II | Active |
| Tumark Vision | 351230 | FDA UDI | Class II | Active |
| Biopsy Handy | 900130 | FDA UDI | Class II | Unknown |
| Tumark Vision | 271590 | FDA UDI | Class II | Unknown |
| Tuflex | 271640 | FDA UDI | Class I | Active |
| Tuloc Premium | 271881 | FDA UDI | Class I | Active |
| Duo System Stereo | 271991 | FDA UDI | Class I | Unknown |
| Tumark Vision | 351232 | FDA UDI | Class II | Active |
| Tumark Eye | 271512 | FDA UDI | Class II | Active |
| Tumark | 271550 | FDA UDI | Class II | Unknown |
| TUMARK Flex | 271570 | FDA UDI | Class II | Unknown |
| Tumark® Professional X for Brevera® Standard | Tumark-BREV-S-X | FDA UDI | Class II | Active |
| Tumark Professional Q-Shape | 271548 | FDA UDI | Class II | Unknown |
| Tumark® Professional Q for Brevera® Petite | Tumark-BREV-P-Q | FDA UDI | Class II | Active |
| Tumark® Vision for Brevera® Standard | TUMARK-BREV-S-V-02 | FDA UDI | Class II | Active |
| Tumark® Vision for Brevera® Petite | Tumark-BREV-P-Vision | FDA UDI | Class II | Active |
| Tumark® Professional Q for Brevera® Petite | TUMARK-BREV-P-Q-02 | FDA UDI | Class II | Active |
| Tuflex Premium | 271651 | FDA UDI | Class I | Active |
| Tumark MRI | 601570 | FDA UDI | Class II | Active |
| Tumark Professional X-Shape | 351210 | FDA UDI | Class II | Active |
| Biopsy Handy | 900120 | FDA UDI | Class II | Unknown |
| Lung Marker System | 272012 | FDA UDI | Class I | Unknown |
| Biopsy Handy | 900136 | FDA UDI | Class II | Unknown |
| Biopsy Handy | 900134 | FDA UDI | Class II | Unknown |
| TUMARK Professional | 271557 | FDA UDI | Class II | Unknown |
| TUMARK Flex | 271576 | FDA UDI | Class II | Unknown |
| Tumark Sphera | 271532 | FDA UDI | Class II | Unknown |
| Tuflex | 271643 | FDA UDI | Class I | Unknown |
| Tumark Conic | 351262 | FDA UDI | Class II | Active |
| Tuloc | 271660 | FDA UDI | Class I | Active |
| Tumark® Professional X for Brevera® Petite | TUMARK-BREV-P-X-02 | FDA UDI | Class II | Active |
| Tumark® Vision for Eviva® Petite | Tumark-E13-P-Vision | FDA UDI | Class II | Active |
| Tumark® Vision for Brevera® Petite | TUMARK-BREV-P-V-02 | FDA UDI | Class II | Active |
| Tuloc | 271661 | FDA UDI | Class I | Active |
| Tumark® Professional Q for Eviva® Petite | Tumark-E13-P-Q | FDA UDI | Class II | Active |
| Tumark® Professional Q for Eviva® Standard | Tumark-E13-S-Q | FDA UDI | Class II | Active |
| Tumark Eye | 351292 | FDA UDI | Class II | Active |
| Tuloc Premium | 271880 | FDA UDI | Class I | Active |
| Tumark Sphera | 351272 | FDA UDI | Class II | Unknown |
| Tumark Vision | K180443 | FDA 510(k) | Class II | Active |
| Tumark Professional, Model 271560, Mr-Tumark Professional, Model 601560 | K093064 | FDA 510(k) | Class II | Active |
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FDA Establishments (1)
Establishments registered with the FDA under this company group, matched by name.
- SOMATEX Medical Technologies GmbH Berlin · DE FEI 3030927217