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NeuroLine Disposable Cranial Perforator with Hudson End
EUDAMEDFDA UDIClass IIa (EU MDR)
Ref NLO-11/14-3.0
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-11/14-3.0 EUDAMEDFDA UDI
- Description
- Disposable Cranial Perforator FDA UDI
Identifiers
- Catalog Number
- NLO-11/14-3.0 FDA UDI
- Primary DI / UDI-DI
- 05999860261001 EUDAMEDFDA UDI
- Basic UDI-DI
- B-05999860261001 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
- Lithuania 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 — MDD, FDA…
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDD
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | B-05999860261001 | Class IIa | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIa | Pending data |
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Manufacturer
- EUDAMED SRN
- HU-MF-000003387
Sources (2)
- EUDAMED a4d6efca-94df-407c-bbba-10f417c2766d 61 fields · synced Oct 7, 2026
- FDA UDI 2de68a25-aeb8-44b2-8dd4-5c5b90a6b328 35 fields · synced May 29, 2026