Identity
- Trade Name
- SHENGTIAN EUDAMED
- Device Name
- Disposable Sampling Swabs EUDAMED
- Model / Reference
- AHM150 EUDAMED001006 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06974478980062 EUDAMED
- Basic UDI-DI
- 697447898AHM150R3 EUDAMED
- EMDN Code
- A1101 SAMPLE COLLECTION NEUTRAL SWABS EUDAMED
Classification
- Device Class
- Class I 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
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Shengtian by Suzhou Shengtian Biotechnology 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 | 697447898AHM150R3 | Class I | Active |
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Manufacturer
- Manufacturer
- Suzhou Shengtian Biotechnology Co., Ltd.
- EUDAMED SRN
- CN-MF-000009632
- Authorised Representative
- MedPath GmbH DE-AR-000000087
Sources (1)
- EUDAMED ff6ef74d-46ed-4b60-bb24-03b47ec95c6f 61 fields · synced Jun 19, 2026