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Disposable Powered Circular Stapler
EUDAMEDClass IIb (EU MDR)
Ref ISC33Model ICS33, ISC33, ICS33L, ICS31,ISC31,ICS31L,ICS29,ISC29,ICS29L,ICS25,ISC25,ICS25L,ICS21,ISC21,ICS21L
Identity
- Trade Name
- Disposable Powered Circular Stapler EUDAMED
- Device Name
- Disposable Powered Circular Stapler EUDAMED
- Model / Reference
- ICS33, ISC33, ICS33L, ICS31,ISC31,ICS31L,ICS29,ISC29,ICS29L,ICS25,ISC25,ICS25L,ICS21,ISC21,ICS21L EUDAMEDISC33 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 16971418900538 EUDAMED
- Basic UDI-DI
- 69714189001208L EUDAMED
- EMDN Code
- H0202020101,H0202020201,H0203020101 EUDAMED
Classification
- Device Class
- Class IIb EUDAMED
- Market of Registration
- Germany EUDAMED
Clinical & Handling
Sterile
Yes
EUDAMED
Implantable
Yes
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
Reprocessed
No
EUDAMED
Sutures
Yes
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
Disposable Powered Circular Stapler by IntoCare Medical Technology (Suzhou) Co., Ltd. — Class IIb — MDR — listed in EUDAMED — regulatory data on deviCERTS
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 | 69714189001208L | Class IIb | Active |
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Manufacturer
- Manufacturer
- IntoCare Medical Technology (Suzhou) Co., Ltd.
- EUDAMED SRN
- CN-MF-000017686
- Authorised Representative
- Llins Service & Consulting GmbH DE-AR-000009077
Sources (1)
- EUDAMED ec1351f4-5d6c-441e-b034-dd50da5e10e0 61 fields · synced Jun 19, 2026