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Modular handles, non HF
EUDAMEDFDA UDIClass I (EU MDR)
Ref 8083.001Model 10000201049
Identity
- Trade Name
- HYSAFE FDA UDI
- Generic Name
- Rigid endoscopic biopsy forceps, reusable FDA UDI
- Device Name
- Modular handles, non HF EUDAMEDHANDLE WITH OVERLOAD PROTECTION take-apart, reusable FDA UDI
- Model / Reference
- 10000201049 EUDAMED8083.001 EUDAMED8083001 FDA UDI
- Description
- HANDLE WITH OVERLOAD PROTECTION take-apart, reusable FDA UDI
Identifiers
- Catalog Number
- 8083.001 FDA UDI
- Primary DI / UDI-DI
- 04055207041130 EUDAMEDFDA UDI
- Basic UDI-DI
- 405520727052019-0017598Q7 EUDAMED
- Direct Marketing DI
- 04055207041130 EUDAMED
- FDA Product Code
- OCZ FDA UDI
- EMDN Code
- L060403 ENDOSCOPIC UROLOGY FORCEPS, REUSABLE EUDAMED
- GMDN Term
- Rigid endoscopic biopsy forceps, reusable FDA UDI
Classification
- Device Class
- Class I EUDAMEDClass II FDA UDI
- Regulation Number
- 876.1500 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
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
No
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
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Modular handles, non HF by Richard Wolf GmbH — 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 | 405520727052019-0017598Q7 | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Richard Wolf GmbH
- EUDAMED SRN
- DE-MF-000007048
Sources (2)
- EUDAMED 745a5529-5d43-47f9-b74c-53b450ae0408 61 fields · synced Jun 18, 2026
- FDA UDI 31b20196-2647-415b-a2ea-f8df4c26b0d5 35 fields · synced May 30, 2026