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Mechanical Accessories Sterilization Net Tray
EUDAMEDFDA UDIClass I (EU MDR)
Ref 366-000322-22Model 700-020834-00
Identity
- Trade Name
- Mechanical Accessories Sterilization Net Tray EUDAMEDFDA UDI
- Generic Name
- Depth electrode FDA UDI
- Device Name
- CRW Non-XY frame Mechanical Set KIT EUDAMED
- Model / Reference
- 700-020834-00 EUDAMED366-000322-22 EUDAMED1 FDA UDI
Identifiers
- Catalog Number
- 366-000322-22 FDA UDI
- Primary DI / UDI-DI
- 07290114061209 EUDAMEDFDA UDI
- Basic UDI-DI
- 729011406123MECHB EUDAMED
- Direct Marketing DI
- 07290114061209 EUDAMED
- 510(k) Number
- K171581 FDA UDI
- FDA Product Code
- GZL FDA UDI
- EMDN Code
- N010199 NEUROPHYSIOLOGY DEVICES - OTHER EUDAMED
- GMDN Term
- Depth electrode FDA UDI
Classification
- Device Class
- Class I 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
No
EUDAMEDFDA UDI
Single Use
No
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
Yes
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
No
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
MR Unsafe FDA UDI
Mechanical Accessories Sterilization Net Tray by Alpha Omega Engineering Ltd — Class I — MDR, FDA UDI — listed in EUDAMED, FDA GUDID
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 | 729011406123MECHB | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | 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 (2)
- EUDAMED 581d0c66-8e3c-43dc-8088-f0c58e42443b 61 fields · synced Jun 17, 2026
- FDA UDI fc60fa4c-42e4-4b04-9055-e0928d0467db 34 fields · synced May 30, 2026