Identity
- Trade Name
- Sealing Connector (T-Piece) EUDAMEDSealing Connector T piece FDA UDI
- Generic Name
- Haemostasis valve FDA UDI
- Device Name
- SEALING CONNECTOR (T-PIECE) EUDAMEDThe Sealing Connectors are a haemostatic valves used in minimally invasive procedures. The valves allow instruments to pass through while preventing blood or other fluids from leaking out. It is designed to maintain a seal around the inserted instruments. FDA UDI
- Model / Reference
- SUR019 EUDAMED1 FDA UDI
- Description
- The Sealing Connectors are a haemostatic valves used in minimally invasive procedures. The valves allow instruments to pass through while preventing blood or other fluids from leaking out. It is designed to maintain a seal around the inserted instruments. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 05906168942259 EUDAMEDFDA UDI
- Basic UDI-DI
- 59061689422SUR019M2 EUDAMED
- FDA Product Code
- EYK FDA UDI
- EMDN Code
- U090199 URINARY STONE RETRIEVAL DEVICES - OTHER EUDAMED
- GMDN Term
- Haemostasis valve FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 876.5130 FDA UDI
- Market of Registration
- Poland EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
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
Yes
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Sealing Connector (T-Piece) by Calyx Medical Sp. z o.o. — 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 | 59061689422SUR019M2 | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Calyx Medical Sp. z o.o.
- EUDAMED SRN
- PL-MF-000038787
Sources (2)
- EUDAMED 1c9bbbbb-8bad-4fbf-8137-5db4f51bf816 61 fields · synced Jul 11, 2026
- FDA UDI 2c4a552f-8d22-471e-9cb4-12e89fdfed96 35 fields · synced May 30, 2026