Identity
- Trade Name
- HiCap FDA UDI
- Generic Name
- In-line backflow valve, reusable FDA UDI
- Device Name
- Trocar valves, metal EUDAMEDMultifunctional Valve, size 11 mm FDA UDI
- Model / Reference
- 30103M2 EUDAMEDFDA UDI
- Description
- Multifunctional Valve, size 11 mm FDA UDI
Identifiers
- Primary DI / UDI-DI
- 04048551117620 EUDAMEDFDA UDI
- Basic UDI-DI
- 4048551001061T7 EUDAMED
- FDA Product Code
- GCJ FDA UDI
- EMDN Code
- Z12029080 VARIOUS INSTRUMENTS FOR ENDOSCOPY AND MINI-INVASIVE SURGERY - HARDWARE ACCESSORIES EUDAMED
- GMDN Term
- In-line backflow valve, reusable FDA UDI
Classification
- Device Class
- Class I 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
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Category: In-line backflow valve, reusable
HiCap 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 In-line backflow valve, reusable.
- Millennium — AVALIGN TECHNOLOGIES, Inc. · Class I
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 |
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Manufacturer
- Manufacturer
- Karl Storz GmbH & Co. KG
Sources (2)
- FDA UDI 5c9949af-e515-412c-9b24-4494ffb02980 33 fields · synced Oct 6, 2026
- EUDAMED eebb259c-565d-4be1-ba72-d0fb2f45fa37 61 fields · synced Jul 29, 2026