Identity
- Trade Name
- SURU EUDAMED
- Device Name
- COLOSTOMY BAG EUDAMED
- Model / Reference
- 3053 EUDAMED3053.250.60 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08902141115402 EUDAMED
- Basic UDI-DI
- 89021413053Q5 EUDAMED
- EMDN Code
- A1001010101 ONE-PIECE COLOSTOMY BAGS FOR NON-RETRACTED STOMA, FLAT, W/O TISSUE COVER EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Germany 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
Suru by Suru International Pvt Ltd — 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 | 89021413053Q5 | Class IIa | Active |
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Manufacturer
- Manufacturer
- Suru International Pvt Ltd
- EUDAMED SRN
- IN-MF-000023736
- Authorised Representative
- CMC Medical Devices & Drugs SL ES-AR-000000293
Sources (1)
- EUDAMED 6b46ecf5-7858-4367-b65a-a822bb8fc82e 61 fields · synced Jul 9, 2026