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Laryngoscopic handles
EUDAMEDFDA UDIClass I (EU MDR)
Ref 82460.0000Model 10000201342
Identity
- Trade Name
- NA FDA UDI
- Generic Name
- Scalpel handle, reusable FDA UDI
- Device Name
- Laryngoscopic handles EUDAMEDHANDLE handle for hand instruments Forhand instruments with diameter until 4,5 mm FDA UDI
- Model / Reference
- 10000201342 EUDAMED82460.0000 EUDAMED824600000 FDA UDI
- Description
- HANDLE handle for hand instruments Forhand instruments with diameter until 4,5 mm FDA UDI
Identifiers
- Catalog Number
- 82460.0000 FDA UDI
- Primary DI / UDI-DI
- 04055207045879 EUDAMEDFDA UDI
- Basic UDI-DI
- 405520727052019-0018449PU EUDAMED
- Direct Marketing DI
- 04055207045879 EUDAMED
- FDA Product Code
- CCW FDA UDI
- EMDN Code
- L140399 LARYNX SURGERY INSTRUMENTS, REUSABLE - OTHER EUDAMED
- GMDN Term
- Scalpel handle, reusable FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 868.5540 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
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
Laryngoscopic handles 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 | 405520727052019-0018449PU | 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 7042b251-1377-4f09-9202-849bcb061d9d 61 fields · synced Jun 19, 2026
- FDA UDI c7498c96-d42a-4f95-94b9-544b85e77079 35 fields · synced May 30, 2026