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Sterile cannula
EUDAMEDFDA UDIClass III (EU MDR)
Ref STR-S00021-31Ref STR-PS5135-00
Identity
- Trade Name
- Sterile cannula EUDAMEDFDA UDI
- Generic Name
- Intracerebral cannula, implantable FDA UDI
- Device Name
- Cannulas and NeuroProbe EUDAMED
- Model / Reference
- STR-S00021-31 EUDAMEDSTR-PS5135-00 EUDAMEDSterile cannula FDA UDI
Identifiers
- Catalog Number
- STR-S00021-31 FDA UDI
- Primary DI / UDI-DI
- 07290114063395 EUDAMEDFDA UDI07290114063425 EUDAMED
- Basic UDI-DI
- 729011406123DISHA EUDAMED
- 510(k) Number
- K120098 FDA UDI
- FDA Product Code
- GZL FDA UDI
- EMDN Code
- N010199 NEUROPHYSIOLOGY DEVICES - OTHER EUDAMED
- GMDN Term
- Intracerebral cannula, implantable FDA UDI
Classification
- Device Class
- Class III EUDAMEDClass II FDA UDI
- Regulation Number
- 882.1330 FDA UDI
- Market of Registration
- Germany 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
Yes
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
No
FDA UDI
MR Unsafe FDA UDI
Sterile cannula by Alpha Omega Engineering Ltd — Class III — 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 | 729011406123DISHA | Class III | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class III | Pending data |
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Manufacturer
- Manufacturer
- Alpha Omega Engineering Ltd
- EUDAMED SRN
- IL-MF-000025214
- Authorised Representative
- Alpha Omega GmbH DE-AR-000022420
Sources (3)
- EUDAMED 48e8c37d-f34e-4fa6-870e-0a7181a67138 61 fields · synced Jul 17, 2026
- EUDAMED d5bea557-1e97-4a24-b11f-2a4a791c68f7 61 fields · synced May 18, 2026
- FDA UDI 5e0e6945-b715-406e-aa60-bfa3ec99457b 34 fields · synced May 30, 2026