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NeoSmile™ Hydrogel - Temperature Probe Cover
EUDAMEDFDA UDIClass I (EU MDR)
Ref N7321Model NeoSmile™
Identity
- Trade Name
- NeoSmile™ Hydrogel - Temperature Probe Cover EUDAMEDNeoSmile™ FDA UDI
- Generic Name
- Electrical cable/lead holder FDA UDI
- Device Name
- NeoSmile™ EUDAMEDNeoSmile is intended to cover and secure a temperature probe. FDA UDI
- Model / Reference
- NeoSmile™ EUDAMEDN7321 EUDAMEDHydrogel FDA UDI
- Description
- NeoSmile is intended to cover and secure a temperature probe. FDA UDI
Identifiers
- Catalog Number
- N7321 FDA UDI
- Primary DI / UDI-DI
- 10812594013437 EUDAMEDFDA UDI
- Basic UDI-DI
- 081259401N73100MH EUDAMED
- FDA Product Code
- KGX FDA UDI
- EMDN Code
- M0599 MEDICAL PLASTERS - OTHER EUDAMED
- GMDN Term
- Electrical cable/lead holder FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 880.5240 FDA UDI
- Market of Registration
- Germany EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
Yes
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
No
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
NeoSmile™ Hydrogel - Temperature Probe Cover by Neotech Products LLC — 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
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 081259401N73100MH | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Neotech Products LLC
- EUDAMED SRN
- US-MF-000001895
- Authorised Representative
- Emergo Europe B.V. NL-AR-000000116
Sources (2)
- EUDAMED 676f8d7a-efdd-4a15-a079-10eb47a36bb6 61 fields · synced Jul 29, 2026
- FDA UDI b47ef9a9-dac0-44bb-b2f7-93ff0dc7a5bb 34 fields · synced May 30, 2026