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Zelf－Katheterisatie Set (Type Man-L)
EUDAMEDClass I (EU MDR)
Ref 800-001-5883HRef 04-4212HRef 800-001-5884HRef 04-4210HRef 04-4216HRef 800-001-5983H
Identity
- Trade Name
- Zelf－Katheterisatie Set (Type Man-L) EUDAMEDZelf－Katheterisatie Set (Type Man) EUDAMED
- Device Name
- Self-Catheterization Set EUDAMED
- Model / Reference
- 800-001-5883H EUDAMED04-4212H EUDAMED800-001-5884H EUDAMED04-4210H EUDAMED04-4216H EUDAMED800-001-5983H EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04542187218824 EUDAMED04542187218732 EUDAMED04542187218831 EUDAMED04542187218725 EUDAMED04542187218756 EUDAMED04542187218879 EUDAMED
- Basic UDI-DI
- 45421870001896 EUDAMED
- EMDN Code
- U010199 URETHRAL PROSTATIC AND BLADDER CATHETERS, NOT SELF-RETAINED - OTHER EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Netherlands EUDAMED
Clinical & Handling
Sterile
No
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
Zelf－Katheterisatie Set (Type Man-L) by Create Medic Co., Ltd. — 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 | 45421870001896 | Class I | Active |
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Manufacturer
- Manufacturer
- Create Medic Co., Ltd.
- EUDAMED SRN
- JP-MF-000010849
- Authorised Representative
- MDSS GmbH DE-AR-000005430
Sources (6)
- EUDAMED 04ee3dbd-f5cb-4bfd-a6ff-1e893c97ac9e 61 fields · synced Sep 17, 2026
- EUDAMED d9640552-0517-49ac-bab7-ac97a0c3ca41 61 fields · synced May 18, 2026
- EUDAMED 0a3c3f40-6f55-4144-9bcc-fd2429bf17cf 61 fields · synced May 18, 2026
- EUDAMED d56abb02-94b8-4a29-ad13-ce715ef000b1 61 fields · synced May 18, 2026
- EUDAMED 8030461e-7e07-4d07-b670-1d6353b755f0 61 fields · synced May 18, 2026
- EUDAMED ca3c6981-71a8-4762-9323-4121a8e92c23 61 fields · synced May 19, 2026