Identity
- Trade Name
- Sim&Size EUDAMEDFDA UDI
- Generic Name
- Radiology DICOM image processing application software FDA UDI
- Device Name
- Sim&Size EUDAMED
- Model / Reference
- 2.0 EUDAMEDV2.0 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 03665786000070 EUDAMEDFDA UDI
- Basic UDI-DI
- 3665786S&SV2ZW EUDAMED
- 510(k) Number
- K242124 FDA UDI
- FDA Product Code
- PZO FDA UDI
- EMDN Code
- Z11030592 RADIOLOGY INSTRUMENTS - MEDICAL DEVICE SOFTWARE EUDAMED
- GMDN Term
- Radiology DICOM image processing application software FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA UDI
- Regulation Number
- 892.2050 FDA UDI
- Special Device Type
- Software EUDAMED
- Market of Registration
- Finland EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
Single Use
No
Implantable
No
Reusable
No
Contains Latex
No
Reprocessed
No
CMR Substance
No
Human-derived
No
Human Tissues
No
Animal Tissues
No
Endocrine Disruptor
No
Administering Medicine
No
Measuring Function
Yes
Incorporates Medicinal Product
No
Prescription Use
Yes
Over-the-Counter
No
Convenience Kit
No
Combination Product
No
HCT/P
No
Premarket Exempt
No
Lot / Batch Number
Yes
Serial Number
No
Expiration Date
No
Manufacturing Date
Yes
The Sim&Size is a measuring device (Nomenclature Code: Z11030592) designed for dimensional assessment, likely in a clinical or training context. Classified as a Class IIa medical device, it incorporates active components to facilitate precise measurements, though it is not intended for implant, reprocessing, or administration of medicines.
Supplied as a non-sterile, single-use device (Reference: 2.0), Sim&Size is intended for use in environments requiring accurate dimensional verification without the need for sterilisation. Authorised under FDA 510K and MDR, it adheres to standard regulatory criteria and carries a Basic UDI (3665786S&SV2ZW) for traceability. No latex, animal, or human tissue components are present, ensuring compatibility with common patient sensitivities.
Frequently asked questions
What is the Sim&Size measuring device used for in a clinical or training setting?
The Sim&Size is designed specifically for **dimensional assessment**, meaning it helps measure and verify precise sizes of anatomical structures or objects in a clinical or training environment. Since it is classified as a Class IIa measuring device, it is likely used where accuracy is critical, such as in surgical planning, anatomical studies, or educational simulations. It is not intended for implanting, administering medicines, or reprocessing.
Is the Sim&Size device sterile, and how should it be handled after opening?
The Sim&Size is **non-sterile** and intended for **single-use only** (Reference: 2.0). Because it is not sterile, it should not be used on patients or in sterile procedures. Instead, it is meant for environments where accurate measurements are needed without sterilization, such as training labs or non-invasive clinical assessments. Always follow manufacturer guidelines for proper disposal after use.
Does the Sim&Size contain any materials that could cause allergic reactions in patients?
No, the Sim&Size does not contain **latex, animal tissues, or human tissues**, making it suitable for patients with common sensitivities or allergies. This ensures compatibility for a broader range of users without risking adverse reactions from these materials.
How can I identify the correct version of the Sim&Size device, and what regulatory approvals does it hold?
The Sim&Size is identified by its **Basic UDI (3665786S&SV2ZW)** and version number (1), which ensures traceability. It has been authorized under **FDA 510K** and **MDR (Medical Device Regulation)**, meaning it meets regulatory standards for safety and performance in both the U.S. and EU markets. Always verify the UDI when ordering to confirm you have the correct version.
Can the Sim&Size be reused, or is it designed for one-time use only?
The Sim&Size is explicitly designed for **single-use only** (Reference: 2.0), meaning it should not be cleaned, reprocessed, or reused after a single application. This design choice ensures reliability and hygiene, particularly in clinical or training settings where precision and contamination control are important.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them.
Authorization Coverage (2 countries)
Regulatory Authorizations
FDA_510K
FDA_510K
FDA_510K
FDA_510K
FDA_510K
FDA_510K
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K190049 | Class IIa | Active |
| FDA 510(k) | United States | FDA_510K | K222664 | Class IIa | Active |
| FDA 510(k) | United States | FDA_510K | K202322 | Class IIa | Active |
| FDA 510(k) | United States | FDA_510K | K212373 | Class IIa | Active |
| FDA 510(k) | United States | FDA_510K | K242124 | Class IIa | Active |
| FDA 510(k) | United States | FDA_510K | K253122 | Class IIa | Active |
| EUDAMED | European Union | CE/MDR | 3665786S&SV2ZW | Class IIa | Active |
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Manufacturer
- Manufacturer
- Sim&Cure
- EUDAMED SRN
- FR-MF-000000319
Sources (3)
- EUDAMED d686fa25-0a3d-4d22-87db-9c08b376dbf2 61 fields · synced Sep 18, 2026
- FDA UDI 8dc9ed82-c659-42c1-b5bb-b785301cee87 33 fields · synced May 30, 2026
- FDA 510(k) K190049 1 fields · synced May 18, 2026