← Back to catalogue
Seer 12
EUDAMEDFDA UDIClass IIa (EU MDR)
Ref 80175-EU1Set, 80175-EU2Set, 80175-EU3Set, 80175-EU4Set, 80175-EU5SetModel SEER 12
Identity
- Trade Name
- SEER 12 EUDAMEDSEER FDA UDI
- Generic Name
- Electrocardiographic ambulatory recorder FDA UDI
- Device Name
- SEER 12 EUDAMEDFDA UDI
- Model / Reference
- SEER 12 EUDAMED80175-EU1Set, 80175-EU2Set, 80175-EU3Set, 80175-EU4Set, 80175-EU5Set EUDAMED12 FDA UDI
- Description
- SEER 12 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00840682108201 EUDAMEDFDA UDI
- Basic UDI-DI
- B-00840682108201 EUDAMED
- 510(k) Number
- K063042 FDA UDI
- FDA Product Code
- MWJ FDA UDI
- EMDN Code
- Z12050403 ECG HOLTER RECORDERS EUDAMED
- GMDN Term
- Electrocardiographic ambulatory recorder FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA UDI
- Regulation Number
- 870.2800 FDA UDI
- Market of Registration
- Germany 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
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
Yes
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Prescription Use
Yes
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
No
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Seer 12 by Getemed Medizin- Und Informationstechnik Ag — Class IIa — MDD, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDD
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | B-00840682108201 | Class IIa | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIa | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- GETEMED Medizin- und Informationstechnik AG
- EUDAMED SRN
- DE-MF-000012384
Sources (2)
- EUDAMED bc2fae54-e079-4803-bbdf-f110bac0f05f 61 fields · synced Jun 8, 2026
- FDA UDI a5b0a3eb-7b96-4f46-b169-49df3ba9a291 36 fields · synced May 30, 2026