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Stethoscope
EUDAMEDFDA UDIClass I (EU MDR)
Ref SC11Ref SC-20Model SC-10, SC-15, SC-20, SC-30Ref SC-30Ref SC23QModel SC11, SC12, SC21, SC12Q, SC23Q, SC23P, SC23C, SC23, SC32, SC22Ref SC-10Ref SC22Ref SC21Ref SC23PRef SC12Q
Identity
- Trade Name
- Stethoscope EUDAMEDCONTEC FDA UDI
- Generic Name
- Mechanical external stethoscope FDA UDI
- Device Name
- Stethoscope EUDAMEDFDA UDI
- Model / Reference
- SC11 EUDAMEDFDA UDISC21 EUDAMEDFDA UDISC-10, SC-15, SC-20, SC-30 EUDAMEDSC-20 EUDAMEDSC-30 EUDAMEDSC11, SC12, SC21, SC12Q, SC23Q, SC23P, SC23C, SC23, SC32, SC22 EUDAMEDSC23Q EUDAMEDSC-10 EUDAMEDSC22 EUDAMEDSC23P EUDAMEDSC12Q EUDAMED
- Description
- Stethoscope FDA UDI
Identifiers
- Primary DI / UDI-DI
- 06945040106135 EUDAMEDFDA UDI06945040106159 EUDAMEDFDA UDI06945040110583 EUDAMED06945040110590 EUDAMED06945040109099 EUDAMED06945040110569 EUDAMED06945040110217 EUDAMED06945040109105 EUDAMED06945040109129 EUDAMED
- Basic UDI-DI
- 69450401SC11N4 EUDAMED69450401SC-10FM EUDAMED
- Direct Marketing DI
- 06945040110583 EUDAMED06945040110590 EUDAMED06945040109099 EUDAMED06945040110569 EUDAMED06945040110217 EUDAMED06945040106159 EUDAMED06945040109105 EUDAMED06945040109129 EUDAMED
- FDA Product Code
- LDE FDA UDI
- EMDN Code
- C9005 PHONENDOSCOPES AND STETHOSCOPES EUDAMED
- GMDN Term
- Mechanical external stethoscope FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 870.1875 FDA UDI
- Market of Registration
- Greece EUDAMEDGermany EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
No
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
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
Prescription Use
No
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
Yes
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Stethoscope by Contec Medical Systems Co., Ltd. — Class I — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 69450401SC11N4 | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Contec Medical Systems Co., Ltd.
- EUDAMED SRN
- CN-MF-000007715
- Authorised Representative
- Prolinx GmbH DE-AR-000005129
Sources (11)
- EUDAMED 34c86f8b-c25d-48e6-8004-7df3c1bbde2a 61 fields · synced Jul 30, 2026
- FDA UDI 70a4fa67-bb69-42db-95d4-6557dfbae65e 33 fields · synced May 30, 2026
- FDA UDI f3e4248a-9928-41c1-8cf0-1416f4739626 33 fields · synced May 30, 2026
- EUDAMED bdb6dfbd-74ee-48ce-8b46-262d90599c6f 61 fields · synced Jul 9, 2026
- EUDAMED 7a7f6455-a906-44cc-b2f2-83cb6b1c30bd 61 fields · synced Jul 9, 2026
- EUDAMED 8fa56987-3f88-452d-817e-44b8a4ae1043 61 fields · synced Jul 9, 2026
- EUDAMED 1f7f0be1-3553-4ac2-ae33-13b849f6ff03 61 fields · synced Jul 12, 2026
- EUDAMED b0bff2ab-1e28-406b-a9bb-000843aa6d79 61 fields · synced Jul 12, 2026
- EUDAMED 3b275db9-33a4-4af4-8291-cbd09a44c00a 61 fields · synced Jul 13, 2026
- EUDAMED 7e07bde5-f53a-4677-9c81-60245adb146b 61 fields · synced Jul 20, 2026
- EUDAMED 8ed75974-f8a5-49ba-bd84-2b4bbb36eea7 61 fields · synced Jul 30, 2026