Identity
- Trade Name
- Simpla Profile EUDAMED
- Device Name
- Simpla Profile leg bag sterile drainable sample port EUDAMED
- Model / Reference
- 21551 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 05701780193863 EUDAMED
- Basic UDI-DI
- 57089322978819N EUDAMED
- EMDN Code
- A06030301 URINE COLLECTION BAGS EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Ireland 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
Simpla Profile by Coloplast A/S — Class I — 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 | 57089322978819N | Class I | Active |
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Manufacturer
- Manufacturer
- Coloplast A/S
- EUDAMED SRN
- DK-MF-000025526
Sources (1)
- EUDAMED 18d245e1-aa25-4c96-a6a1-5e019abd7a4e 61 fields · synced Jun 17, 2026