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Surgical laparoscopic sheaths
EUDAMEDFDA UDIClass I (EU MDR)
Ref 8753.004Model 10000201417
Identity
- Trade Name
- NA FDA UDI
- Generic Name
- Endoscope sheath, reusable FDA UDI
- Device Name
- Surgical laparoscopic sheaths EUDAMEDINNER SHEATH FOR HYSTEROSCOPE color code blue, working channel 5 Fr, compatible with outer sheath 8753.003, reusable FDA UDI
- Model / Reference
- 10000201417 EUDAMED8753.004 EUDAMED8753004 FDA UDI
- Description
- INNER SHEATH FOR HYSTEROSCOPE color code blue, working channel 5 Fr, compatible with outer sheath 8753.003, reusable FDA UDI
Identifiers
- Catalog Number
- 8753.004 FDA UDI
- Primary DI / UDI-DI
- 04055207020357 EUDAMEDFDA UDI
- Basic UDI-DI
- 405520711062019-0018676F3 EUDAMED
- Direct Marketing DI
- 04055207020357 EUDAMED
- FDA Product Code
- HIH FDA UDI
- EMDN Code
- U0999 UROGENITAL ENDOSCOPIC DEVICES - OTHER EUDAMED
- GMDN Term
- Endoscope sheath, reusable FDA UDI
Classification
- Device Class
- Class I EUDAMEDClass II FDA UDI
- Regulation Number
- 884.1690 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
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
Surgical laparoscopic sheaths 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 | 405520711062019-0018676F3 | 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 9c7e982d-2ecf-43dd-974b-cc1cde3857e5 61 fields · synced Jul 10, 2026
- FDA UDI 3a623e55-11d5-4300-9e05-1d1d86aa662d 36 fields · synced May 30, 2026