Identity
- Trade Name
- Aesculap EUDAMEDFDA UDI
- Generic Name
- Rigid optical laparoscope FDA UDI
- Device Name
- Endoscope EUDAMEDLAPAROSCOPE 5MM O DEG 310MM FDA UDI
- Model / Reference
- PE590A EUDAMEDFDA UDI
- Description
- LAPAROSCOPE 5MM O DEG 310MM FDA UDI
Identifiers
- Catalog Number
- PE590A FDA UDI
- Primary DI / UDI-DI
- 04038653300662 EUDAMEDFDA UDI
- Basic UDI-DI
- 40392390000027393B EUDAMED
- FDA Product Code
- HRX 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
- 888.1100 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
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
Reprocessed
No
EUDAMED
CMR Substance
Yes
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
No
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Aesculap by Aesculap AG — 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 | 40392390000027393B | Class IIa | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIa | Pending data |
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Manufacturer
- Manufacturer
- Aesculap AG
- EUDAMED SRN
- DE-MF-000005504
Sources (2)
- EUDAMED 2f8d9af9-c227-406b-8b81-ba141d8a34c6 61 fields · synced Jul 28, 2026
- FDA UDI fa024909-290e-4a4b-b85b-f7ee64adac36 35 fields · synced May 29, 2026