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Iron
EUDAMEDClass IIa (EU MDR)
Ref AS-35KModel AS-35A, AS-35E, AS-35I, AS-35K, AS-35H, AS-35X, AS-35W, BA6310, BA4900, BA4110
Identity
- Trade Name
- IRON EUDAMED
- Device Name
- Automated non-invasive Sphygmomanometer EUDAMED
- Model / Reference
- AS-35A, AS-35E, AS-35I, AS-35K, AS-35H, AS-35X, AS-35W, BA6310, BA4900, BA4110 EUDAMEDAS-35K EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06947707703916 EUDAMED
- Basic UDI-DI
- 6947707706016CS EUDAMED
- Direct Marketing DI
- 06947707703916 EUDAMED
- EMDN Code
- Z1203020302 NON–INVASIVE BLOOD PRESSURE MONITORING INSTRUMENTS EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Türkiye 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
Yes
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Iron by Xiamen Ants-Bro Technology Co., Ltd. — 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 | 6947707706016CS | Class IIa | Active |
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Manufacturer
- Manufacturer
- Xiamen Ants-Bro Technology Co., Ltd.
- EUDAMED SRN
- CN-MF-000010562
- Authorised Representative
- SUNGO Europe B.V. NL-AR-000000247
Sources (1)
- EUDAMED 143b8cc8-661c-4e64-8c04-25e0008bba4b 61 fields · synced Jun 11, 2026