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Laparoscope
EUDAMEDFDA UDIClass IIa (EU MDR)
Ref 20533FAModel 21033FA, 21033FC, 21033WA, 21033WC, 20533FA, 20533FC, 20533WA, 20533WC
Identity
- Trade Name
- Laparoscope EUDAMEDFDA UDI
- Generic Name
- Rigid optical laparoscope FDA UDI
- Device Name
- Laparoscope EUDAMED
- Model / Reference
- 21033FA, 21033FC, 21033WA, 21033WC, 20533FA, 20533FC, 20533WA, 20533WC EUDAMED20533FA EUDAMEDFDA UDI
Identifiers
- Primary DI / UDI-DI
- 06973031299603 EUDAMEDFDA UDI
- Basic UDI-DI
- 697303129YJ02SA01S9 EUDAMED
- Direct Marketing DI
- 06973031299603 EUDAMED
- 510(k) Number
- K231003 FDA UDI
- FDA Product Code
- GCJ FDA UDIHET FDA UDINMH FDA UDI
- EMDN Code
- Z12029009 LAPAROSCOPES EUDAMED
- GMDN Term
- Rigid optical laparoscope FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA UDI
- Regulation Number
- 876.1500 FDA UDI884.1720 FDA UDI
- Market of Registration
- Ireland 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
Laparoscope by Guangdong Optomedic Technologies, 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 | 697303129YJ02SA01S9 | Class IIa | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIa | Pending data |
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Manufacturer
- Manufacturer
- Guangdong Optomedic Technologies, Inc.
- EUDAMED SRN
- CN-MF-000011588
- Authorised Representative
- Share info GmbH DE-AR-000005132
Sources (2)
- EUDAMED 19ff006c-14eb-487f-853b-50373ff5e52f 61 fields · synced May 30, 2026
- FDA UDI 0fd5a173-2897-4f2a-b5c6-0c6fc2491ebc 33 fields · synced May 30, 2026