Disposable Laparoscopic Trocar
by Changzhou Tongchuang Medical Instrument Technology Co., Ltd. 14 variants
Ref TCCA3M, TCCB5L, TCCA15L, TCCB12M, TCCB15L, TCCE5L, TCCA10M, TCCB12L, TCCC12X, TCCC6X, TCCA12L, TCCB10M, TCCE10L, TCCB10LModel Type A/E, Type B, Type C
Active
CE MDR
Valid until
Not listed
FDA recalls
Not applicable
Documents
None linked in EUDAMED
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | Number695479091830P7 | Date23 Mar 2026 | StatusActive |
Certificates
EUDAMED lists no certificate for this device's Basic UDI-DI.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
European Union — CE/MDR Active
Specification
- Trade Name
- Disposable Laparoscopic TrocarBluesail surgical
- Device Name
- Disposable Laparoscopic Trocar Kits
- Model / Reference
- Type A/E, TCCA3M, Type B, TCCB5L, TCCA15L, TCCB12M, TCCB15L, TCCE5L, TCCA10M, TCCB12L, Type C, TCCC12X, TCCC6X, TCCA12L, TCCB10M, TCCE10L, TCCB10L
- Primary DI / UDI-DI
- 06954790918318, 06954790918530, 06954790918479, 06954790918615, 06954790918653, 06954790900245, 06954790918400, 06954790918622, 06954790918684, 06954790918660, 06954790918448, 06954790918585, 06954790900306, 06954790918592
- Basic UDI-DI
- 695479091830P7, 695479091848PS, 695479091601NN, B-06954790918660
- EMDN Code
- K01010101, K01010199
- Device Class
- Class IIa
- EU market of registration
- GermanyRomania
Manufacturer details
- EUDAMED SRN
- CN-MF-000028788
- Authorised representative
- Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001
Other devices from Changzhou Tongchuang Medical Instrument Technology Co., Ltd.
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Properties
Other properties (12)
- Implantable: No
- Reusable: No
- Contains Latex: No
- Reprocessed: No
- CMR Substance: No
- Human-derived: No
- Human Tissues: No
- Animal Tissues: No
- Endocrine Disruptor: No
- Administering Medicine: No
- Measuring Function: No
- Incorporates Medicinal Product: No