← Back to catalogue
Pulse Oximeter
EUDAMEDClass IIb (EU MDR)
Ref HS20A-LIModel HS10ARef FS20LModel FS20ARef FS20FRef FS10CRef FS20DRef FS20E2Ref FS10F3Ref FS10B2Ref FS10FRef FS10ERef FS20BRef FS20C1Ref FS20C2Ref FS20D1Ref HS20A (PD)Ref FS20PRef HS10A-LiRef FS20A Ref FS10I3Ref FS20NRef FS10ARef FS20CRef FS20ERef FS20N1Ref FS10IRef HS20A-LiRef FS20KRef FS10C2
Identity
- Trade Name
- Pulse Oximeter EUDAMED
- Device Name
- Pulse Oximeter EUDAMED
- Model / Reference
- HS10A EUDAMEDHS20A-LI EUDAMEDFS20A EUDAMEDFS20L EUDAMEDFS20F EUDAMEDFS10C EUDAMEDFS20D EUDAMEDFS20E2 EUDAMEDFS10F3 EUDAMEDFS10B2 EUDAMEDFS10F EUDAMEDFS10E EUDAMEDFS20B EUDAMEDFS20C1 EUDAMEDFS20C2 EUDAMEDFS20D1 EUDAMEDHS20A (PD) EUDAMEDFS20P EUDAMEDHS10A-Li EUDAMEDFS10I3 EUDAMEDFS20N EUDAMEDFS10A EUDAMEDFS20C EUDAMEDFS20E EUDAMEDFS20N1 EUDAMEDFS10I EUDAMEDFS20K EUDAMEDFS10C2 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06927394533362 EUDAMED06927394500142 EUDAMED06927394502412 EUDAMED06927394501897 EUDAMED06927394502108 EUDAMED06927394500623 EUDAMED06927394500449 EUDAMED06927394502924 EUDAMED06927394500272 EUDAMED06927394501934 EUDAMED06927394501910 EUDAMED06927394501804 EUDAMED06927394501866 EUDAMED06927394500579 EUDAMED06927394501873 EUDAMED06927394500586 EUDAMED06927394500593 EUDAMED06927394533355 EUDAMED06927394500777 EUDAMED06927394500852 EUDAMED06927394500821 EUDAMED06927394500470 EUDAMED08425402188705 EUDAMED06927394500685 EUDAMED06927394501811 EUDAMED06927394577762 EUDAMED06927394501835 EUDAMED06927394501842 EUDAMED06927394500692 EUDAMED06927394501941 EUDAMED03701063804426 EUDAMED06927394500869 EUDAMED06927394501859 EUDAMED06927394502580 EUDAMED06927394503136 EUDAMED06927394503112 EUDAMED
- Basic UDI-DI
- 69273945PO02WC EUDAMED69273945PO01WA EUDAMEDB-06927394501897 EUDAMEDB-06927394501934 EUDAMEDB-06927394501910 EUDAMEDB-06927394501804 EUDAMEDB-06927394501866 EUDAMEDB-06927394501873 EUDAMEDB-06927394501811 EUDAMEDB-06927394501835 EUDAMEDB-06927394501842 EUDAMEDB-06927394501941 EUDAMEDB-06927394501859 EUDAMED
- Direct Marketing DI
- 06927394533362 EUDAMED06927394500142 EUDAMED06927394502412 EUDAMED06927394502108 EUDAMED06927394500623 EUDAMED06927394500449 EUDAMED06927394502924 EUDAMED06927394500272 EUDAMED06927394500579 EUDAMED06927394500586 EUDAMED06927394500593 EUDAMED06927394533355 EUDAMED06927394500777 EUDAMED06927394500852 EUDAMED06927394500821 EUDAMED06927394500470 EUDAMED08425402188705 EUDAMED06927394500685 EUDAMED06927394577762 EUDAMED06927394500692 EUDAMED03701063804426 EUDAMED06927394500869 EUDAMED06927394502580 EUDAMED06927394503136 EUDAMED06927394503112 EUDAMED
- EMDN Code
- Z1203020408 PULSE OXIMETERS EUDAMED
Classification
- Device Class
- Class IIb EUDAMEDClass IIa EUDAMED
- Market of Registration
- Türkiye EUDAMEDGermany EUDAMEDFrance EUDAMEDHungary EUDAMEDSpain EUDAMEDPoland 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
EUDAMEDEUDAMED
Incorporates Medicinal Product
No
EUDAMED
Pulse Oximeter by Hunan Accurate Bio-Medical Technology Co., Ltd. — Class IIb — MDD, MDR — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDD
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | 69273945PO02WC | Class IIb | Active |
| EUDAMED | European Union | CE/MDR | 69273945PO02WC | Class IIb | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Hunan Accurate Bio-Medical Technology Co., Ltd.
- EUDAMED SRN
- CN-MF-000012835
- Authorised Representative
- Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001
Sources (36)
- EUDAMED 2785920e-452a-410c-8d00-4a6a16566e21 61 fields · synced Oct 7, 2026
- EUDAMED 84df38b3-8139-4d87-98d0-45b8033c1e70 61 fields · synced May 11, 2026
- EUDAMED fbbae043-9ffb-44b5-97c2-abb2f83828fb 61 fields · synced May 11, 2026
- EUDAMED 14e06c27-45f2-4b77-9726-5144333d24b3 61 fields · synced May 11, 2026
- EUDAMED 568e504a-759e-4431-8895-332806cb017b 61 fields · synced May 16, 2026
- EUDAMED c5cee514-9f5b-4836-bdb5-b2d9d450e7d7 61 fields · synced May 16, 2026
- EUDAMED 6298c517-2547-41bb-8690-9d6caf3a09f9 61 fields · synced May 16, 2026
- EUDAMED f911ccb2-1d2a-4345-878e-b7f5de90811e 61 fields · synced May 17, 2026
- EUDAMED ec8a9c10-f22b-4e08-ab5d-a3adba637735 61 fields · synced May 17, 2026
- EUDAMED a37764f9-730b-4fe1-8472-3f1139db1b32 61 fields · synced May 17, 2026
- EUDAMED e87c40ee-af13-4856-a0fa-65a56fe32daa 61 fields · synced May 17, 2026
- EUDAMED bc97a852-debe-400d-9422-01fd33786b77 61 fields · synced May 17, 2026
- EUDAMED 0821e137-f765-44b1-b9e2-9d9014552393 61 fields · synced May 17, 2026
- EUDAMED 46982674-16a6-4a9b-9b1a-e66c4b100c86 61 fields · synced May 17, 2026
- EUDAMED dac703fe-b23f-4d16-963e-c719a0e66ffc 61 fields · synced May 17, 2026
- EUDAMED 22ba4648-d29d-4a06-9abf-496a7aeae39e 61 fields · synced May 17, 2026
- EUDAMED ac1e2e36-5553-43e5-b76e-b8635e3ec08b 61 fields · synced May 18, 2026
- EUDAMED 07ffd56e-08e8-4053-a7b7-aee4c0b49e19 61 fields · synced May 18, 2026
- EUDAMED 36a37880-4377-488f-ab26-7625fc1215cd 61 fields · synced May 18, 2026
- EUDAMED ab52869a-7dda-47dc-a6fb-3fbabf42e187 61 fields · synced May 18, 2026
- EUDAMED 6b646c3f-7a04-4b5f-b85a-1e11d951b14c 61 fields · synced May 18, 2026
- EUDAMED 0f090f01-69e9-46c6-9f6e-c50192d0f569 61 fields · synced May 18, 2026
- EUDAMED 7c242d08-a590-47fe-8e35-2d4cd30dd60d 61 fields · synced May 18, 2026
- EUDAMED 0b61877f-16d3-4b4c-a491-633dec80cb4a 61 fields · synced May 19, 2026
- EUDAMED 77092eb6-5e4d-401f-803c-87a0b8a6f52c 61 fields · synced May 19, 2026
- EUDAMED a3ebc51b-61aa-4cf1-bcf4-d7a9c766b5ce 61 fields · synced May 19, 2026
- EUDAMED aa7a5567-cdd3-4ad9-8b9b-051dca34b82b 61 fields · synced May 19, 2026
- EUDAMED 84bd4b57-ab68-4efa-892a-5413a8262a68 61 fields · synced May 19, 2026
- EUDAMED e9f7494f-c866-43b5-8456-e2803e19268f 61 fields · synced May 19, 2026
- EUDAMED 24b22664-92e8-469c-ac69-22fca132cdc8 61 fields · synced May 19, 2026
- EUDAMED b5138610-0640-4310-b8e1-7954abdd14c9 61 fields · synced May 19, 2026
- EUDAMED 3187cb60-1411-4125-ba10-33c42b8c09ad 61 fields · synced May 19, 2026
- EUDAMED 7300a95b-1f87-4d0e-a4e0-2b2c7fa76791 61 fields · synced May 19, 2026
- EUDAMED 9ce7e207-0fc0-4ed2-add5-8e666a4b7997 61 fields · synced Jul 10, 2026
- EUDAMED 434aa06b-f1db-446e-9e8b-f9cbaafc210a 61 fields · synced Jul 15, 2026
- EUDAMED 490dac25-1d19-45f3-b7fe-874e084dbe25 61 fields · synced Jul 19, 2026