Identity
- Device Name
- Sterile Protective cap for single use EUDAMED
- Model / Reference
- ZRSPS-10-R EUDAMED
Identifiers
- Primary DI / UDI-DI
- 16930197882268 EUDAMED
- Basic UDI-DI
- 69301978202101s03801F7 EUDAMED
- EMDN Code
- A070501 CAPS OR OBTURATORS, NON-PERFORABLE EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Netherlands 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
Sterile Protective cap for single use by Shanghai Kindly Enterprise Development Group Co., Ltd. — Class I — MDR — listed in EUDAMED
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 | 69301978202101s03801F7 | Class I | Active |
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Manufacturer
- EUDAMED SRN
- CN-MF-000005652
- Authorised Representative
- Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001
Sources (1)
- EUDAMED 14148d4a-e26a-4976-b471-2429ed55a5a5 61 fields · synced Jun 19, 2026