Identity
- Trade Name
- NightGuard Firm 2 EUDAMEDSprintRay Nightguard Firm 2 - Midnight Purple -1 Kg FDA UDI
- Generic Name
- Dental appliance fabrication material, resin FDA UDI
- Device Name
- NightGuard Firm 2 - Midnight Purple EUDAMEDSprintRay NightGuard Firm 2 is indicated for the fabrication of dental appliances such as mouthguards and nightguards. FDA UDI
- Model / Reference
- SRI-0202147 EUDAMEDFDA UDI
- Description
- SprintRay NightGuard Firm 2 is indicated for the fabrication of dental appliances such as mouthguards and nightguards. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00850039704642 EUDAMEDFDA UDI
- Basic UDI-DI
- 0850039704SRI-0202147HG EUDAMED
- FDA Product Code
- KMY FDA UDI
- EMDN Code
- Q0102050199 DENTISTRY RESINS - OTHER EUDAMED
- GMDN Term
- Dental appliance fabrication material, resin FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 872.5525 FDA UDI
- Market of Registration
- Germany EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
No
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
Reprocessed
No
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Dimensions & Sizes
- Size
- Weight — 1 Kilogram FDA UDI
NightGuard Firm 2 by Sprintray, Inc. — Class I — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDR
European Union Active
CE/MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 0850039704SRI-0202147HG | Class I | Active |
| EUDAMED | European Union | CE/MDR | 0850039704SRI-0202147HG | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Sprintray Inc.
- EUDAMED SRN
- US-MF-000036081
- Authorised Representative
- SprintRay Europe GmbH DE-AR-000033436
Sources (2)
- EUDAMED 7a21b195-4535-4b1f-8766-3eda4ff3e8fe 61 fields · synced Jun 1, 2026
- FDA UDI 0f73f3f5-be08-41dc-b65f-e6ac4193274c 36 fields · synced May 24, 2026