Identity
- Trade Name
- E-LINE FDA UDI
- Generic Name
- Pin-indexed adaptor, reusable FDA UDI
- Device Name
- Adapters EUDAMEDINSTRUMENT PORT 4FR TL 31 mm, capacity for instruments up to 4 Fr, compatible with working element 8652.781, with introduction port, reusable FDA UDI
- Model / Reference
- 10000201463 EUDAMED8652.788 EUDAMED8652788 FDA UDI
- Description
- INSTRUMENT PORT 4FR TL 31 mm, capacity for instruments up to 4 Fr, compatible with working element 8652.781, with introduction port, reusable FDA UDI
Identifiers
- Catalog Number
- 8652.788 FDA UDI
- Primary DI / UDI-DI
- 04055207018583 EUDAMEDFDA UDI
- Basic UDI-DI
- 405520727052019-0028504PN EUDAMED
- Direct Marketing DI
- 04055207018583 EUDAMED
- FDA Product Code
- GEA 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 EUDAMEDFDA UDI
- Regulation Number
- 878.4800 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
Dimensions & Sizes
- Size
- Outer Diameter — 1.33333333333 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 | 405520727052019-0028504PN | 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 638b3e7e-b706-4295-8461-bab4ebc82c63 61 fields · synced Aug 4, 2026
- FDA UDI ae1b0604-4465-43d0-86b7-07d913c2aecb 37 fields · synced May 30, 2026