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Closed Suction Systems
EUDAMEDClass IIa (EU MDR)
Ref 12Fr（CSS-B12TY）Model XTGRef 10Fr（CSS-A10TY）Ref 16Fr（CSS-A16EY）Ref 10Fr（CSS-B10EY）Ref NARef 14Fr（CSS-A14TY）Ref 6Fr（CSS-A06PY）Ref 8Fr（CSS-A08PY）Ref 14Fr（CSS-A14EY）Ref 16Fr（CSS-B16TY）Ref 16Fr（CSS-A16TY）Ref 12Fr（CSS-A12TY）Ref 14Fr（CSS-B14EY）Ref 5Fr（CSS-B05PY）Ref 10Fr（CSS-B10TY）Ref 16Fr（CSS-B16EY）Ref 14Fr（CSS-B14TY）Ref 7Fr（CSS-A07PY）Ref 12Fr（CSS-B12EY）
Identity
- Trade Name
- Closed Suction Systems EUDAMED
- Device Name
- Closed Suction Systems EUDAMED
- Model / Reference
- XTG EUDAMED12Fr（CSS-B12TY） EUDAMED10Fr（CSS-A10TY） EUDAMED16Fr（CSS-A16EY） EUDAMED10Fr（CSS-B10EY） EUDAMEDNA EUDAMED14Fr（CSS-A14TY） EUDAMED6Fr（CSS-A06PY） EUDAMED8Fr（CSS-A08PY） EUDAMED14Fr（CSS-A14EY） EUDAMED16Fr（CSS-B16TY） EUDAMED16Fr（CSS-A16TY） EUDAMED12Fr（CSS-A12TY） EUDAMED14Fr（CSS-B14EY） EUDAMED5Fr（CSS-B05PY） EUDAMED10Fr（CSS-B10TY） EUDAMED16Fr（CSS-B16EY） EUDAMED14Fr（CSS-B14TY） EUDAMED7Fr（CSS-A07PY） EUDAMED12Fr（CSS-B12EY） EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06970531335466 EUDAMED06970531334018 EUDAMED26970531335057 EUDAMED06970531334179 EUDAMED16970531332387 EUDAMED06970531332458 EUDAMED26970531334036 EUDAMED26970531334265 EUDAMED16970531334084 EUDAMED06970531335015 EUDAMED06970531332588 EUDAMED06970531334636 EUDAMED16970531332394 EUDAMED26970531334746 EUDAMED06970531334025 EUDAMED26970531335330 EUDAMED26970531335255 EUDAMED36970531332404 EUDAMED16970531335258 EUDAMED06970531332472 EUDAMED26970531332476 EUDAMED06970531335060 EUDAMED06970531332335 EUDAMED26970531335064 EUDAMED26970531334197 EUDAMED16970531335418 EUDAMED06970531332434 EUDAMED06970531335381 EUDAMED06970531334124 EUDAMED06970531335534 EUDAMED16970531332448 EUDAMED06970531335503 EUDAMED26970531332445 EUDAMED06970531335411 EUDAMED06970531334650 EUDAMED26970531334630 EUDAMED26970531334890 EUDAMED16970531335425 EUDAMED26970531332278 EUDAMED16970531335340 EUDAMED06970531332366 EUDAMED16970531334121 EUDAMED06970531335022 EUDAMED26970531334067 EUDAMED26970531335095 EUDAMED26970531334173 EUDAMED06970531334278 EUDAMED26970531334708 EUDAMED26970531334814 EUDAMED26970531334616 EUDAMED06970531334186 EUDAMED
- Basic UDI-DI
- 697053133cssXK EUDAMED
- Direct Marketing DI
- 06970531335466 EUDAMED06970531334018 EUDAMED26970531335057 EUDAMED06970531334179 EUDAMED16970531332387 EUDAMED06970531332458 EUDAMED26970531334036 EUDAMED26970531334265 EUDAMED16970531334084 EUDAMED06970531335015 EUDAMED06970531332588 EUDAMED06970531334636 EUDAMED16970531332394 EUDAMED26970531334746 EUDAMED06970531334025 EUDAMED26970531335330 EUDAMED26970531335255 EUDAMED36970531332404 EUDAMED16970531335258 EUDAMED06970531332472 EUDAMED26970531332476 EUDAMED06970531335060 EUDAMED06970531332335 EUDAMED26970531335064 EUDAMED26970531334197 EUDAMED16970531335418 EUDAMED06970531332434 EUDAMED06970531335381 EUDAMED06970531334124 EUDAMED06970531335534 EUDAMED16970531332448 EUDAMED06970531335503 EUDAMED26970531332445 EUDAMED06970531335411 EUDAMED06970531334650 EUDAMED26970531334630 EUDAMED26970531334890 EUDAMED16970531335425 EUDAMED26970531332278 EUDAMED16970531335340 EUDAMED06970531332366 EUDAMED16970531334121 EUDAMED06970531335022 EUDAMED26970531334067 EUDAMED26970531335095 EUDAMED26970531334173 EUDAMED06970531334278 EUDAMED26970531334708 EUDAMED26970531334814 EUDAMED26970531334616 EUDAMED06970531334186 EUDAMED
- EMDN Code
- R050102 CLOSED-CIRCUIT RESPIRATORY SUCTION AND IRRIGATION SYSTEMS (NON-ENDOSCOPIC) EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Greece EUDAMED
Clinical & Handling
Sterile
Yes
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
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
Closed Suction Systems are a medical device designed for the administration of suction therapy in various surgical and medical procedures. These systems are characterized by their ability to provide gentle, controlled suction while minimizing tissue damage. With its advanced features and robust design, Closed Suction Systems are ideal for a range of applications, from cosmetic surgery to urological procedures.
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 697053133cssXK | Class IIa | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Shaoxing Undis Medical Technology Co., Ltd
- EUDAMED SRN
- CN-MF-000002187
- Authorised Representative
- Lotus NL B.V. NL-AR-000000121
Sources (51)
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