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Troge
EUDAMEDClass IIa (EU MDR)
Ref Standard Ⅰ CS 10#Ref Standard Ⅰ CS 22#Ref Standard Ⅰ CS 36#Ref Standard Ⅰ CS 23#Ref Standard Ⅰ CS 20#Ref Standard Ⅰ CS 18#Ref Standard Ⅰ CS 15#Ref Standard Ⅰ CS 24#Ref Standard Ⅰ CS 12#Ref CS 23#Ref CS 15#Ref CS 12#
Identity
- Trade Name
- TROGE EUDAMED
- Device Name
- Disposable Scalpels EUDAMEDDisposable Surgical Blades EUDAMED
- Model / Reference
- Standard Ⅰ CS 10# EUDAMEDStandard Ⅰ CS 22# EUDAMEDStandard Ⅰ CS 36# EUDAMEDStandard Ⅰ CS 23# EUDAMEDStandard Ⅰ CS 20# EUDAMEDStandard Ⅰ CS 18# EUDAMEDStandard Ⅰ CS 15# EUDAMEDStandard Ⅰ CS 24# EUDAMEDStandard Ⅰ CS 12# EUDAMEDCS 23# EUDAMEDCS 15# EUDAMEDCS 12# EUDAMED
Identifiers
- Primary DI / UDI-DI
- 16945630142274 EUDAMED16945630142328 EUDAMED16945630142359 EUDAMED16945630142335 EUDAMED16945630142304 EUDAMED16945630142298 EUDAMED16945630142090 EUDAMED16945630142342 EUDAMED16945630142281 EUDAMED16945630143691 EUDAMED16945630143653 EUDAMED16945630143646 EUDAMED
- Basic UDI-DI
- 6945630107BM EUDAMED6945630110BA EUDAMED
- Unit of Use DI
- 06945630142277 EUDAMED06945630142321 EUDAMED06945630142352 EUDAMED06945630142338 EUDAMED06945630142307 EUDAMED06945630142291 EUDAMED06945630142093 EUDAMED06945630142345 EUDAMED06945630142284 EUDAMED06945630143694 EUDAMED06945630143656 EUDAMED06945630143649 EUDAMED
- EMDN Code
- V010101 SCALPELS WITH SAFETY SYSTEMS, SINGLE-USE EUDAMEDV010302 BLADES WITHOUT SAFETY SYSTEMS, SINGLE-USE - NOT INCLUDED IN OTHER CLASSES EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Austria EUDAMEDGermany 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
Troge by Sterilance Medical (Suzhou) Inc. — Class IIa — 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 | 6945630107BM | Class IIa | Active |
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Manufacturer
- Manufacturer
- Sterilance Medical (Suzhou) Inc.
- EUDAMED SRN
- CN-MF-000002860
- Authorised Representative
- Emergo Europe B.V. NL-AR-000000116
Sources (12)
- EUDAMED e9f50bbb-e7c4-4d0d-9d37-a34a90ef0a5f 61 fields · synced Jul 30, 2026
- EUDAMED d4374e6b-b4b5-4c6f-919d-eb8c12493d2a 61 fields · synced May 16, 2026
- EUDAMED 0a112595-cdbb-4939-8694-f3078f4d39f2 61 fields · synced May 16, 2026
- EUDAMED c7f1b05e-c608-46f3-bc1d-50223d886c1b 61 fields · synced May 17, 2026
- EUDAMED f54afe51-0d46-401b-8a87-65f11698d421 61 fields · synced May 17, 2026
- EUDAMED a1f39f0a-16fb-4d94-9348-e247b8fab4e9 61 fields · synced May 18, 2026
- EUDAMED 9bedbf7c-fb90-45a2-a3d4-326fcd0b8394 61 fields · synced May 18, 2026
- EUDAMED 2496e80e-fa1b-4ffe-83f0-8ad5259b1dce 61 fields · synced May 18, 2026
- EUDAMED a329166a-92fc-4c93-820d-f3a14e1bb351 61 fields · synced May 18, 2026
- EUDAMED 963c564e-c065-4cc1-b912-80c32785035c 61 fields · synced Jun 14, 2026
- EUDAMED f87a9806-3d8a-4af5-b931-cd6130eccb16 61 fields · synced Jun 18, 2026
- EUDAMED 833cbaf1-5e92-421b-815c-bd0b6c831995 61 fields · synced Jul 14, 2026