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Guide tubes for laser therapy
EUDAMEDFDA UDIClass I (EU MDR)
Ref 82510.0011Model 10000201357
Identity
- Trade Name
- NA FDA UDI
- Generic Name
- General/multiple surgical laser system beam guide, reusable FDA UDI
- Device Name
- Guide tubes for laser therapy EUDAMEDLASER GUIDE TUBE ID 0.8MM WL 450MM reusable FDA UDI
- Model / Reference
- 10000201357 EUDAMED82510.0011 EUDAMED825100011 FDA UDI
- Description
- LASER GUIDE TUBE ID 0.8MM WL 450MM reusable FDA UDI
Identifiers
- Catalog Number
- 82510.0011 FDA UDI
- Primary DI / UDI-DI
- 04055207033470 EUDAMEDFDA UDI
- Basic UDI-DI
- 405520727052019-0018468PY EUDAMED
- Direct Marketing DI
- 04055207033470 EUDAMED
- FDA Product Code
- KTI FDA UDI
- EMDN Code
- L080899 BRONCHOSCOPIC SURGERY INSTRUMENTS, REUSABLE - OTHER EUDAMED
- GMDN Term
- General/multiple surgical laser system beam guide, reusable FDA UDI
Classification
- Device Class
- Class I EUDAMEDClass II FDA UDI
- Regulation Number
- 874.4680 FDA UDI
- Market of Registration
- Germany EUDAMED
- Commercial Distribution
- Not 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
Yes
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
Dimensions & Sizes
- Size
- Length — 450 Millimeter FDA UDILumen/Inner Diameter — 0.8 Millimeter FDA UDI
Guide tubes 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 | 405520727052019-0018468PY | 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 7d8ee680-1f59-4a45-b0cf-7acaf3156960 61 fields · synced Jun 19, 2026
- FDA UDI 244a3880-7654-4374-82ad-0bde433ab12d 37 fields · synced May 30, 2026