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Shengtian
EUDAMEDClass I (EU MDR)
Ref 001004Model PHM150Ref 001016Model PM150Ref 001013Model PSX150Ref 001015Model MM150Ref 001005Model AHM70Ref 001014Model GPX150Ref 001011Model GARY150Ref 001012Model GAR150Ref 001009Model AR150
Identity
- Trade Name
- SHENGTIAN EUDAMED
- Device Name
- Disposable Sampling Swabs EUDAMED
- Model / Reference
- PHM150 EUDAMED001004 EUDAMEDPM150 EUDAMED001016 EUDAMEDPSX150 EUDAMED001013 EUDAMEDMM150 EUDAMED001015 EUDAMEDAHM70 EUDAMED001005 EUDAMEDGPX150 EUDAMED001014 EUDAMEDGARY150 EUDAMED001011 EUDAMEDGAR150 EUDAMED001012 EUDAMEDAR150 EUDAMED001009 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06974478980048 EUDAMED06974478980161 EUDAMED06974478980130 EUDAMED06974478980154 EUDAMED06974478980055 EUDAMED06974478980147 EUDAMED06974478980116 EUDAMED06974478980123 EUDAMED06974478980093 EUDAMED
- Basic UDI-DI
- 697447898PHM150X6 EUDAMED697447898PM150T3 EUDAMED697447898PSX1505F EUDAMED697447898MM150S2 EUDAMED697447898AHM70R8 EUDAMED697447898GPX150YN EUDAMED697447898GARY15082 EUDAMED697447898GAR150S7 EUDAMED697447898AR150NZ 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 | 697447898PHM150X6 | 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 (9)
- EUDAMED 9e86dc51-730d-47af-932f-1cfac709e719 61 fields · synced Aug 3, 2026
- EUDAMED 7f066abf-057e-47e3-8110-fad057176f7c 61 fields · synced May 16, 2026
- EUDAMED 029bb95b-162a-4cbc-9f3e-04009b09608d 61 fields · synced May 17, 2026
- EUDAMED 04ab3f01-5114-42a1-81ea-738d22a3ae0b 61 fields · synced May 17, 2026
- EUDAMED 5a417d3e-ea47-4b89-83ea-341198895502 61 fields · synced May 17, 2026
- EUDAMED 53757ec3-b37f-407b-b3f8-663ef93ab427 61 fields · synced May 17, 2026
- EUDAMED dd37a28a-a83e-4ab7-aa86-2e83e5450604 61 fields · synced May 17, 2026
- EUDAMED 6d2b4688-db1a-4f2a-b774-4bc451d9dee9 61 fields · synced May 18, 2026
- EUDAMED b599f555-8964-4679-be9a-e93054740b19 61 fields · synced May 19, 2026