Identity
- Trade Name
- OptiHair2 EUDAMEDFDA UDI
- Generic Name
- Point aesthesiometer FDA UDI
- Device Name
- The "OptiHair2" - von Frey filaments are used to investigate the tactile detection threshold in quantitative sensory testing (QST). FDA UDI
- Model / Reference
- OptiHair2 EUDAMEDVF FDA UDI
- Description
- The "OptiHair2" - von Frey filaments are used to investigate the tactile detection threshold in quantitative sensory testing (QST). FDA UDI
Identifiers
- Primary DI / UDI-DI
- 04262355232109 EUDAMEDFDA UDI
- Basic UDI-DI
- 426235523OptiHair28F EUDAMED
- FDA Product Code
- GXB FDA UDI
- EMDN Code
- Z12101106 NEUROLOGICAL STIMULATORS EUDAMED
- GMDN Term
- Point aesthesiometer FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 882.1500 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
No
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
Yes
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
Yes
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Point aesthesiometer
OptiHair2 by MRC SYSTEMS GmbH Medizintechnische Systeme — Class I — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
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Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Unknown
MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class I | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- MRC SYSTEMS GmbH Medizintechnische Systeme
Sources (2)
- FDA UDI 3d8552f8-7233-43a2-a7ac-2f0431d42e6b 34 fields · synced Jul 16, 2026
- EUDAMED 6e9d6d41-af81-4205-910e-91d72184864c 61 fields · synced Jul 16, 2026