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SC760 High Suction Controller / High, Direct probe
EUDAMEDFDA UDIClass I (EU MDR)
Ref 310101
Identity
- Trade Name
- SC760 High Suction Controller / High, Direct probe EUDAMEDPenlon FDA UDI
- Generic Name
- Vacuum suction regulator/regulation set, general-purpose FDA UDI
- Device Name
- General-purpose suction vacuum regulator EUDAMEDHIGH SUCTION CONTROLLER+DIRECT PROBE FDA UDI
- Model / Reference
- 310101 EUDAMEDFDA UDI
- Description
- HIGH SUCTION CONTROLLER+DIRECT PROBE FDA UDI
Identifiers
- Catalog Number
- 310101 FDA UDI
- Primary DI / UDI-DI
- 05051977000178 EUDAMEDFDA UDI
- Basic UDI-DI
- 5051977SCO-SC7608H EUDAMED
- FDA Product Code
- GCX FDA UDI
- EMDN Code
- A0601010299 DRAINAGE SYSTEMS WITH ADJUSTABLE SUCTION - OTHER EUDAMED
- GMDN Term
- Vacuum suction regulator/regulation set, general-purpose FDA UDI
Classification
- Device Class
- Class I EUDAMEDClass II FDA UDI
- Regulation Number
- 880.6740 FDA UDI
- Market of Registration
- Ireland 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
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
SC760 High Suction Controller / High, Direct probe by Penlon Limited — 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 | 5051977SCO-SC7608H | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Penlon Limited
- EUDAMED SRN
- GB-MF-000025115
- Authorised Representative
- Obelis s.a. BE-AR-000000106
Sources (2)
- EUDAMED b1d2a690-a2c3-410b-81e3-591dd1b737bd 61 fields · synced Jun 19, 2026
- FDA UDI 154bb50c-567d-41c8-95e6-aba793b16e73 34 fields · synced May 30, 2026