Identity
- Trade Name
- ADTEC SOVEREIGN EUDAMEDFDA UDI
- Generic Name
- Rigid endoscopic tissue manipulation forceps, reusable FDA UDI
- Device Name
- SOVEREIGN grasping forceps EUDAMEDADTEC SOVEREIGN Grasping Forceps, complete instrument, (360 mm), diam. 5 mm, with sliding ratchet, double action, reusable FDA UDI
- Model / Reference
- PL235R EUDAMEDFDA UDI
- Description
- ADTEC SOVEREIGN Grasping Forceps, complete instrument, (360 mm), diam. 5 mm, with sliding ratchet, double action, reusable FDA UDI
Identifiers
- Catalog Number
- PL235R FDA UDI
- Primary DI / UDI-DI
- 04046964074882 EUDAMEDFDA UDI
- Basic UDI-DI
- 40392390000006572S EUDAMED
- Direct Marketing DI
- 04046964074882 EUDAMED
- FDA Product Code
- HTD FDA UDI
- EMDN Code
- L1204 LAPAROSCOPIC AND THORACOSCOPIC SURGERY FORCEPS, REUSABLE EUDAMED
- GMDN Term
- Rigid endoscopic tissue manipulation forceps, reusable FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 878.4800 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
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Adtec Sovereign by Aesculap AG — Class I — 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 | 40392390000006572S | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Aesculap AG
- EUDAMED SRN
- DE-MF-000005504
Sources (2)
- EUDAMED 70a31701-ac24-48d8-983c-d5216e75ddcd 61 fields · synced Jul 8, 2026
- FDA UDI f3b53197-da9f-416f-be55-608ac627da4d 36 fields · synced May 29, 2026