Identity
- Trade Name
- Blood Sampler EUDAMED
- Device Name
- Blood Sampler EUDAMED
- Model / Reference
- isafeP-1N EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06944413837928 EUDAMED
- Basic UDI-DI
- 69444138isafePSBW EUDAMED
- EMDN Code
- A02010502 BLOOD GAS ANALYSIS, SYRINGES WITH SAFETY NEEDLE AND KITS 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
Yes
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Blood Sampler by Edan Instruments, Inc. — 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 | 69444138isafePSBW | Class IIa | Active |
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Manufacturer
- Manufacturer
- Edan Instruments, Inc.
- EUDAMED SRN
- CN-MF-000009957
- Authorised Representative
- Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001
Sources (1)
- EUDAMED b9f1f324-e800-4a0d-8100-5f70c108d94c 61 fields · synced Jun 18, 2026