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Histofreezer Professional - H602
EUDAMEDClass IIa (EU MDR)
Ref 1001-0408Model Histofreezer Professional - H-602, Germany
Identity
- Trade Name
- Histofreezer Professional - H602 EUDAMED
- Device Name
- Histofreezer Portable Cryosurgical System EUDAMED
- Model / Reference
- Histofreezer Professional - H-602, Germany EUDAMED1001-0408 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00850077006135 EUDAMED
- Basic UDI-DI
- B-00850077006135 EUDAMED
- EMDN Code
- Z120102 CRYOSURGERY EQUIPMENT EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Germany EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
Reprocessed
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Histofreezer Professional - H602 by Cryoconcepts, Lp — Class IIa — MDD — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | B-00850077006135 | Class IIa | Active |
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Manufacturer
- Manufacturer
- CryoConcepts, LP
- EUDAMED SRN
- US-MF-000009822
- Authorised Representative
- Emergo Europe B.V. NL-AR-000000116
Sources (1)
- EUDAMED 97dbee5f-ba2d-4e83-bb34-686cc38f60a2 61 fields · synced Jun 20, 2026