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Simpla Profile
EUDAMEDClass I (EU MDR)
Ref 21564Ref 21593Ref 21594Ref 21563Ref 21573Ref 21556
Identity
- Trade Name
- Simpla Profile EUDAMED
- Device Name
- Simpla Profile leg bag sterile drainable sample port EUDAMEDSimpla Profile bedside drainage bag sterile EtO drainable sample port EUDAMED
- Model / Reference
- 21564 EUDAMED21593 EUDAMED21594 EUDAMED21563 EUDAMED21573 EUDAMED21556 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 05701780193924 EUDAMED05701780194020 EUDAMED05701780194037 EUDAMED05701780193917 EUDAMED05701780193986 EUDAMED05701780193887 EUDAMED
- Basic UDI-DI
- 57089322978819N EUDAMED57089322978939V 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 (6)
- EUDAMED 23c88427-c7c5-44d6-8633-4da0f00f37dc 61 fields · synced Jul 31, 2026
- EUDAMED 767ce948-ee69-4176-b382-5296315047d4 61 fields · synced May 16, 2026
- EUDAMED 270d14e5-48ca-40cc-abb2-91dcc44040c7 61 fields · synced May 17, 2026
- EUDAMED 5bcd5624-b8c7-4f33-bffe-06b153a7b170 61 fields · synced May 17, 2026
- EUDAMED d4666ce9-2888-4ad6-af76-d4ab93cca511 61 fields · synced May 17, 2026
- EUDAMED e2cd5304-ad86-4bd5-8c1e-2c503445a43b 61 fields · synced May 18, 2026