Identity
- Trade Name
- Quantum FDA UDI
- Generic Name
- Sensor holder, single-use FDA UDI
- Device Name
- Quantum Reservoir Level Sensor Cradle Curved Taper (Box of 100) EUDAMEDQuantum Reservoir Level Sensor Cradle - Curved Taper FDA UDI
- Model / Reference
- LSC_HRCT EUDAMEDFDA UDI
- Description
- Quantum Reservoir Level Sensor Cradle - Curved Taper FDA UDI
Identifiers
- Catalog Number
- LSC_HRCT FDA UDI
- Primary DI / UDI-DI
- 05060434423986 EUDAMEDFDA UDI
- Basic UDI-DI
- 506043442LSCDH EUDAMED
- FDA Product Code
- KRI FDA UDI
- EMDN Code
- C030199 EXTRACORPOREAL AND ASSISTED CIRCULATION DEVICES - OTHER EUDAMED
- GMDN Term
- Sensor holder, single-use FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 870.4200 FDA UDI
- Market of Registration
- Germany EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
Yes
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
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Sensor holder, single-use
Quantum by Spectrum Medical Limited — Class I — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
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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 I | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Spectrum Medical Limited
Sources (2)
- FDA UDI 48a4bcc5-96f5-4ef3-ab8f-ad6d7a945bca 36 fields · synced Aug 1, 2026
- EUDAMED 50db4e98-c826-4ff9-a66b-6eaef5cb39e8 61 fields · synced Aug 1, 2026