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NeuroLine Disposable Cranial Perforator with Hudson End
EUDAMEDFDA UDIFDA 510(k)Class IIa (EU MDR)
Ref NLO-9/13-3.0510(k) K213228
by EMD Endoszkóp Műszer Gyártó és Kereskedelmi Korlátolt Felelősségű Társaság
Identity
- Trade Name
- NeuroLine Disposable Cranial Perforator with Hudson End EUDAMEDNeuroLine FDA UDI
- Generic Name
- Automatic cranial perforator, single-use FDA UDI
- Device Name
- NeuroLine Disposable Cranial Perforator with Hudson End EUDAMEDDisposable Cranial Perforator FDA UDI
- Model / Reference
- NLO-9/13-3.0 EUDAMEDFDA UDI
- Description
- Disposable Cranial Perforator FDA UDI
Identifiers
- Catalog Number
- NLO-9/13-3.0 FDA UDI
- Primary DI / UDI-DI
- 05999860261230 EUDAMEDFDA UDI
- Basic UDI-DI
- B-05999860261230 EUDAMED
- 510(k) Number
- K213228 FDA UDI
- FDA Product Code
- HBF FDA UDI
- EMDN Code
- P091304 CRANIAL PERFORATORS, SINGLE-USE EUDAMED
- GMDN Term
- Automatic cranial perforator, single-use FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA UDI
- Regulation Number
- 882.4305 FDA UDI
- Market of Registration
- Hungary 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
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
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
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
NeuroLine Disposable Cranial Perforator with Hudson End by EMD Endoszkóp Műszer Gyártó és Kereskedelmi Korlátolt Felelősségű Társaság — Class IIa — FDA_510K…
Authorization Coverage (2 countries)
Regulatory Authorizations
United States Active
FDA_510K
European Union Active
CE/MDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K213228 | Class IIa | Active |
| EUDAMED | European Union | CE/MDD | B-05999860261230 | Class IIa | Active |
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Manufacturer
- EUDAMED SRN
- HU-MF-000003387
- FDA Applicant
- Emd Endoszkop Muszer Gyarto ES Kereskedelmi Kft.
Sources (3)
- EUDAMED 5846d44f-7aed-499d-ab3b-af6c94775c24 85 fields · synced Jun 18, 2026
- FDA UDI b3ff50ae-c247-4d08-94f2-b4dca4727eec 35 fields · synced May 30, 2026
- FDA 510(k) K213228 1 fields · synced May 18, 2026