Identity
- Trade Name
- HOPKINS FDA UDI
- Generic Name
- Rigid optical hysteroscope FDA UDI
- Device Name
- Telescopes, hysteroscopy EUDAMEDHOPKINS® Telescope 12°, 2.9 mm, 30 cm FDA UDI
- Model / Reference
- 26020FA EUDAMEDFDA UDI
- Description
- HOPKINS® Telescope 12°, 2.9 mm, 30 cm FDA UDI
Identifiers
- Primary DI / UDI-DI
- 04048551091296 EUDAMEDFDA UDI
- Basic UDI-DI
- 4048551000196TQ EUDAMED
- FDA Product Code
- FAJ FDA UDI
- EMDN Code
- Z12020704 HYSTEROSCOPES EUDAMED
- GMDN Term
- Rigid optical hysteroscope FDA UDI
Classification
- Device Class
- Class IIa 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
Yes
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
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Rigid optical hysteroscope
Hopkins by Karl Storz GmbH & Co. KG — Class II — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as Rigid optical hysteroscope.
- TruClear — Covidien LP · Class II
- BR Surgical, LLC — BR SURGICAL LLC · Class II
- TRUCLEAR — Smith & Nephew, Inc. · Class II
- MyoSure XL Rod Lens Hysteroscope — Hologic, Inc. · Class II
- Hysteroscope — SOPRO-COMEG GmbH · Class II
- Gimmi — Gimmi GmbH · Class II
- AED — NATIONAL ADVANCED ENDOSCOPY DEVICES, INC. · Class II
- TruClear — Covidien LP · Class II
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Unknown
MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class II | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Karl Storz GmbH & Co. KG
Sources (2)
- FDA UDI 14f0f3fd-65fb-478f-8e84-fd8f53b5090e 33 fields · synced Jul 18, 2026
- EUDAMED 7624b98d-54cd-47c7-9f70-f44cd315a2b8 61 fields · synced Jul 18, 2026