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Laser working elements for laser therapy
EUDAMEDFDA UDIClass I (EU MDR)
Ref 8654.282Model 10000201107
Identity
- Trade Name
- NA FDA UDI
- Generic Name
- Resectoscope FDA UDI
- Device Name
- Laser working elements for laser therapy EUDAMEDLASER WORKING ELEMENT PASSIVE 12/30° open, with locking mechanism for laser fibers, compatible with telescopes Ø 4mm, bayonet-cap, reusable FDA UDI
- Model / Reference
- 10000201107 EUDAMED8654.282 EUDAMED8654282 FDA UDI
- Description
- LASER WORKING ELEMENT PASSIVE 12/30° open, with locking mechanism for laser fibers, compatible with telescopes Ø 4mm, bayonet-cap, reusable FDA UDI
Identifiers
- Catalog Number
- 8654.282 FDA UDI
- Primary DI / UDI-DI
- 04055207018781 EUDAMEDFDA UDI
- Basic UDI-DI
- 405520721052019-0017694FA EUDAMED
- Direct Marketing DI
- 04055207018781 EUDAMED
- FDA Product Code
- FDC FDA UDI
- EMDN Code
- U090299 UROGENITAL ENDOSCOPIC RESECTION INSTRUMENTS - OTHER EUDAMED
- GMDN Term
- Resectoscope 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
Laser working elements for laser therapy 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 | 405520721052019-0017694FA | 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 f6270dbf-1031-4301-b0f0-8f5a472155d2 61 fields · synced Jul 13, 2026
- FDA UDI 2a250ad3-9515-45b0-af41-11814a24be60 35 fields · synced May 30, 2026