Identity
- Trade Name
- E-LINE FDA UDI
- Generic Name
- Pin-indexed adaptor, reusable FDA UDI
- Device Name
- Adapters EUDAMEDCONNECTING PART RESECTOSCOPE 26FR color code black, TL 22mm, rotatable, compatible with 26Fr E-Line sheaths, quick-lock, reusable FDA UDI
- Model / Reference
- 10000201447 EUDAMED8654.3842 EUDAMED86543842 FDA UDI
- Description
- CONNECTING PART RESECTOSCOPE 26FR color code black, TL 22mm, rotatable, compatible with 26Fr E-Line sheaths, quick-lock, reusable FDA UDI
Identifiers
- Catalog Number
- 8654.3842 FDA UDI
- Primary DI / UDI-DI
- 04055207028063 EUDAMEDFDA UDI
- Basic UDI-DI
- 405520711032019-0028403AE EUDAMED
- Direct Marketing DI
- 04055207028063 EUDAMED
- FDA Product Code
- FJL FDA UDI
- EMDN Code
- L060413 ENDOSCOPIC UROLOGY ADAPTERS AND CONNECTORS, REUSABLE EUDAMED
- GMDN Term
- Pin-indexed adaptor, 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
Dimensions & Sizes
- Size
- Outer Diameter — 8.66666666666 Millimeter FDA UDI
Adapters 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 | 405520711032019-0028403AE | 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 11436c47-e273-4667-b4bd-d0e5dc73c303 61 fields · synced May 30, 2026
- FDA UDI 0516785b-90c7-4583-a3e7-9dd8c72d0edc 37 fields · synced May 30, 2026