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Visualase™ Neuro Accessories and Tools
EUDAMEDFDA UDIClass IIa (EU MDR)
Ref 9736536
by FHC Inc.
Identity
- Trade Name
- Visualase™ Neuro Accessories and Tools EUDAMEDVisualase Neuro Accessories FDA UDI
- Generic Name
- Neurological stereotactic surgery system FDA UDI
- Device Name
- Visualase Neuro Accessories EUDAMEDVisualase Neuro Accessories (1) Anchor Bolt (1) Stiffening Stylet (1) Anchor Bolt Removal Tool FDA UDI
- Model / Reference
- 9736536 EUDAMED9736536-00906 FDA UDI
- Description
- Visualase Neuro Accessories (1) Anchor Bolt (1) Stiffening Stylet (1) Anchor Bolt Removal Tool FDA UDI
Identifiers
- Catalog Number
- 9736536 FDA UDI
- Primary DI / UDI-DI
- 00873263009314 EUDAMED00873263009062 FDA UDI
- Basic UDI-DI
- 087326300.12-100-1-A.TD EUDAMED
- FDA Product Code
- HAO FDA UDIGAH FDA UDI
- EMDN Code
- Z12100685 STEREOTACTIC NEUROSURGERY INSTRUMENTS - CONSUMABLES EUDAMED
- GMDN Term
- Neurological stereotactic surgery system FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass I FDA UDI
- Regulation Number
- 882.4535 FDA UDI878.4800 FDA UDI
- Market of Registration
- France EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
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
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
Ethylene Oxide FDA UDI
MR Unsafe FDA UDI
Visualase™ Neuro Accessories and Tools by Fhc, Inc. — Class IIa — 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 | 087326300.12-100-1-A.TD | Class IIa | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIa | Pending data |
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Manufacturer
- Manufacturer
- FHC Inc.
- EUDAMED SRN
- US-MF-000012111
- Authorised Representative
- TERMOBIT PROD SRL RO-AR-000010668
Sources (2)
- EUDAMED afc0756c-ef06-4745-ad60-a450aa14730b 61 fields · synced Jun 17, 2026
- FDA UDI 9cea72f4-52c5-4539-98a0-cbb736943c0f 35 fields · synced May 30, 2026