SafetiHeel, MediHeel, Novaplus
FDA 510(k)EUDAMEDClass II (US FDA 510(k))
Identity
- Trade Name
- SafetiHEEL EUDAMED
- Device Name
- SafetiHEEL EUDAMED
- Model / Reference
- SH-065 EUDAMEDSH-150 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08887629010335 EUDAMED08887629010038 EUDAMED
- Basic UDI-DI
- 8887629SH4Y EUDAMED
- Unit of Use DI
- 08887629010304 EUDAMED08887629010007 EUDAMED
- 510(k) Number
- K221604 FDA 510(k)
- FDA Product Code
- FMK FDA 510(k)
- EMDN Code
- V010401 LANCETS WITH SAFETY SYSTEMS, SINGLE-USE EUDAMED
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 878.4850 FDA 510(k)
- Regulation Number
- 878.4850 FDA 510(k)
- Advisory Committee
- General, Plastic Surgery FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
Clinical & Handling
Sterile
Yes
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
No
Incorporates Medicinal Product
No
The SafetiHeel SH-100 is a single-use blood lancet with an integral sharps injury prevention feature, classified under product code FMK. It is designed as a contact-activated device for safe and gentle blood sampling, specifically for infants and newborns, incorporating a usage indicator to enhance safety and usability.
This device is intended for single-use in clinical settings, including hospitals and pediatric care environments. It is regulated under the FDA 510(k) clearance (K221604) and MDR, with a classification as substantially equivalent (SESE) to predicate devices. The device is non-sterile as supplied and must be handled according to standard medical device protocols to ensure proper functionality and safety.
Frequently asked questions
What is the SafetiHeel SH-100 designed for and in which clinical settings is it typically used?
The SafetiHeel SH-100 is a single-use blood lancet specifically engineered for safe and gentle blood sampling in infants and newborns. Its contact-activated design and integral sharps injury prevention feature make it ideal for clinical settings like hospitals and pediatric care environments where minimizing pain and reducing injury risks are critical.
How do I know if the SafetiHeel SH-100 has been used, and why is this feature important?
The SafetiHeel SH-100 includes a usage indicator to visually confirm whether the device has been activated and used. This feature enhances safety by preventing accidental reuse, which could compromise sterility and patient safety, especially in pediatric populations where proper infection control is paramount.
Is the SafetiHeel SH-100 sterile as supplied, and what handling precautions should I take?
The device is non-sterile as supplied, meaning it must be sterilized or prepared according to standard medical device protocols before use. Since it is intended for single-use, proper sterilization and adherence to clinical protocols are essential to ensure functionality and patient safety during blood sampling.
What regulatory pathways has the SafetiHeel SH-100 followed, and what does ‘substantially equivalent’ mean in this context?
The SafetiHeel SH-100 has undergone FDA 510(k) clearance (K221604) and MDR compliance, with a classification of substantially equivalent (SESE) to predicate devices. This designation means the FDA determined that the device has the same intended use and technological characteristics as legally marketed predecessors, ensuring it meets regulatory standards for safety and effectiveness.
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. Sources consulted: SafetiHeel, MediHeel, Novaplus (K221604) — FDA 510 (k) | Innolitics, SAFETiHEEL™ SH-100 - NSP Tech, SafetiHeel, MediHeel, Novaplus 510(k) K221604 - FDA.report, SafetiHeel, MediHeel, Novaplus — FDA 510(k) K221604
Authorization Coverage (2 countries)
Regulatory Authorizations
MDR
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class II | Active |
| FDA 510(k) | United States | FDA_510K | K221604 | Class II | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Nsp Tech Pte, Ltd.
Sources (3)
- FDA 510(k) K221604 24 fields · synced Sep 18, 2026
- EUDAMED ec5df75a-534f-4cca-bbb2-9b3a313be21e 61 fields · synced Jul 11, 2026
- EUDAMED 5dcda706-900d-493f-bbdc-753a324775b0 61 fields · synced Jul 12, 2026