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Adapters and sealing caps
EUDAMEDFDA UDIClass I (EU MDR)
Ref 8020.15Model 10000201534
Identity
- Trade Name
- NA FDA UDI
- Generic Name
- Endoscope sheath, reusable FDA UDI
- Device Name
- Adapters and sealing caps EUDAMEDUNIVERSAL CAP FOR BRONCH. reusable FDA UDI
- Model / Reference
- 10000201534 EUDAMED8020.15 EUDAMED802015 FDA UDI
- Description
- UNIVERSAL CAP FOR BRONCH. reusable FDA UDI
Identifiers
- Catalog Number
- 8020.15 FDA UDI
- Primary DI / UDI-DI
- 04055207008843 EUDAMEDFDA UDI
- Basic UDI-DI
- 405520711082021-0037416CD EUDAMED
- Direct Marketing DI
- 04055207008843 EUDAMED
- FDA Product Code
- LLO FDA UDI
- EMDN Code
- Z12020480 INSTRUMENTS FOR THE ACQUISITION AND MANAGEMENT OF ENDOSCOPIC AND MINIMALLY INVASIVE SURGERY IMAGES - HARDWARE ACCESSORIES EUDAMED
- GMDN Term
- Endoscope sheath, reusable FDA UDI
Classification
- Device Class
- Class I EUDAMEDClass II FDA UDI
- Regulation Number
- 874.4500 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
Adapters and sealing caps 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 | 405520711082021-0037416CD | 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 ed05ac21-ab94-41ee-bb95-fa8abe73fca7 61 fields · synced Jul 22, 2026
- FDA UDI b44dbb18-a7f9-4767-b9ab-efece65eed0d 35 fields · synced May 30, 2026