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index Asurity STERiLANCE
EUDAMEDClass IIa (EU MDR)
Ref Asurity 4# SS 22#Ref Asurity 4# SS 23#Ref Asurity 3# SS 11#Ref Asurity 4# SS 18#Ref Asurity 3# SS 12#Ref Asurity 3# SS 15#Ref Asurity 4# SS 24#Ref Asurity SS #11Ref Asurity 4# SS 21#Ref "Asurity SS #11 22-0311"
Identity
- Trade Name
- index Asurity STERiLANCE EUDAMED"index Asurity STERiLANCE " EUDAMED
- Device Name
- Disposable Scalpels EUDAMED
- Model / Reference
- Asurity 4# SS 22# EUDAMEDAsurity 4# SS 23# EUDAMEDAsurity 3# SS 11# EUDAMEDAsurity 4# SS 18# EUDAMEDAsurity 3# SS 12# EUDAMEDAsurity 3# SS 15# EUDAMEDAsurity 4# SS 24# EUDAMEDAsurity SS #11 EUDAMEDAsurity 4# SS 21# EUDAMED"Asurity SS #11 22-0311" EUDAMED
Identifiers
- Primary DI / UDI-DI
- 16945630140263 EUDAMED16945630140270 EUDAMED16945630140843 EUDAMED16945630140201 EUDAMED16945630140232 EUDAMED16945630140218 EUDAMED16945630140225 EUDAMED16945630140287 EUDAMED16945630143004 EUDAMED16945630140256 EUDAMED16945630143530 EUDAMED
- Basic UDI-DI
- 6945630103BD EUDAMED6945630122BH EUDAMED
- Unit of Use DI
- 06945630140266 EUDAMED06945630140273 EUDAMED06945630140846 EUDAMED06945630140204 EUDAMED06945630140235 EUDAMED06945630140211 EUDAMED06945630140228 EUDAMED06945630140280 EUDAMED06945630143007 EUDAMED06945630140259 EUDAMED06945630143533 EUDAMED
- EMDN Code
- V010101 SCALPELS WITH SAFETY SYSTEMS, SINGLE-USE EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Portugal EUDAMEDAustria EUDAMEDSpain 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
index Asurity STERiLANCE 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 | 6945630103BD | 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 (11)
- EUDAMED 56bf332d-db4a-49a0-9045-834f34991279 61 fields · synced Aug 4, 2026
- EUDAMED efeeff73-90c8-4723-9ac7-9fff9fa20537 61 fields · synced May 16, 2026
- EUDAMED a6d2ee1c-f579-42be-9fbe-8fe40de5682e 61 fields · synced May 16, 2026
- EUDAMED d04a8b67-5f02-45c8-9467-9aa2f9fb8968 61 fields · synced May 17, 2026
- EUDAMED 60aecf45-429d-44df-b2ef-830a607da7bd 61 fields · synced May 17, 2026
- EUDAMED a580be4a-0a9e-4b4a-8275-868c8431d1e8 61 fields · synced May 17, 2026
- EUDAMED f2335419-0a62-4eec-b5ee-e03d7803d4ca 61 fields · synced May 18, 2026
- EUDAMED 94b0b188-69dc-4c03-8ca8-06be754864b7 61 fields · synced May 19, 2026
- EUDAMED f2b070c5-acc5-4099-bae2-a64822d3c3c2 61 fields · synced May 19, 2026
- EUDAMED fd911dcc-b4fb-4ee7-9593-a1730dbc569f 61 fields · synced May 19, 2026
- EUDAMED 6f2c50c5-3537-4ce2-96ae-114ae608a0e9 61 fields · synced Jul 16, 2026