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Gynecological sheaths
EUDAMEDFDA UDIClass I (EU MDR)
Ref 8753.003Model 10000201270
Identity
- Trade Name
- NA FDA UDI
- Generic Name
- Endoscope sheath, reusable FDA UDI
- Device Name
- Gynecological sheaths EUDAMEDOUTER SHEATH FOR HYSTEROSCOPE 15FR color code blue, WL 214 mm, oval, working channel 5 Fr, compatible with hysteroscopy telescope 8753.411, reusable FDA UDI
- Model / Reference
- 10000201270 EUDAMED8753.003 EUDAMED8753003 FDA UDI
- Description
- OUTER SHEATH FOR HYSTEROSCOPE 15FR color code blue, WL 214 mm, oval, working channel 5 Fr, compatible with hysteroscopy telescope 8753.411, reusable FDA UDI
Identifiers
- Catalog Number
- 8753.003 FDA UDI
- Primary DI / UDI-DI
- 04055207020340 EUDAMEDFDA UDI
- Basic UDI-DI
- 405520711032019-0018270A8 EUDAMED
- Direct Marketing DI
- 04055207020340 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
Dimensions & Sizes
- Size
- Outer Diameter — 5 Millimeter FDA UDI
Gynecological 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 | 405520711032019-0018270A8 | 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 ff4fe5ee-030c-4abc-857b-bccc9ab6c03f 61 fields · synced Jul 31, 2026
- FDA UDI 600d3586-6dd1-486f-a267-6e5783abba54 37 fields · synced May 30, 2026